Search Results For : " UNIVERSITY OF BIRMINGHAMBIRMIN "
Calendario de la Junta Directiva - Agenda e Informes
will now be held at the following address:
Dr. Bradley P. Gilbert Center for Learning & Innovation
9500 Cleveland Ave.
Rancho Cucamonga, CA 91730
Click here to view the meeting room map.
Any Member of the public may observe the scheduled proceedings by using the link listed below.
March 6, 2023 - 9 a.m.
Click here to join the virtual meeting.
March 2023
Agenda
Board Report
Under $200k Summary Report
January 2023
Agenda
Board Report
Under $200k Summary Report
MediCal - Ancillary
ly contracted provider.
PLEASE NOTE, IEHP is currently not accepting new:
DME
Hospice
Specialty Pharmacy
Clinical Laboratories
Please check monthly for updates on Network Availability.
Prior to extending a contract, we must receive the following documents:
1. Ancillary Provider Network Participation Request Form (PDF)
2. W-9 Form
A current Taxpayer Identification Number and Certification Form
3. Liability Insurance Certificate
Professional general liability in the minimum amount of One Million Dollars ($1,000,000) per occurrence.
Three Million Dollars ($3,000,000) aggregate per year for professional liability.
4. Ownership Information (PDF)
Name, Title and Percentage of Ownership
5. Provider Accreditation Certificate
6. CMS/DHCS Passing Site Survey (Approval Letter)
Required for each facility
7. California State License (if applicable)
Required for each facility
8. Urgent Care Minimum Qualifications (if applicable)
All Ages (PDF)
Pediatrics (PDF)
9. Medi-Cal Number
Ancillary Providers need to successfully enroll in the State's Medi-Cal Program
10. Provider Acknowledgment of Receipt (AOR) (PDF)
IEHP is required by State and Federal regulators to maintain an AOR form on file for our Providers signifying your receipt and review of the Policy & Procedure manuals, including annual updates
11. Electronic Remittance Advice (ERA) Form (PDF)
Ancillary Providers must complete the ERA form
Contracts Maintenance Request Form can be found here (PDF).
Any delay in receiving the above stated documents will affect the effective date of the contract that will be mailed to you.
The contract collateral and other supporting contract documents should be e-mailed to contract@iehp.org.
You will need Adobe Acrobat Reader 6.0 or later to view the PDF files. You can download a free copy by clicking here.
IEHP DualChoice - Medicamentos recetados
en los requisitos de los CMS para el acceso a farmacias en su área. Hay más de 700 farmacias en la red de IEHP DualChoice. Los proveedores de la red de IEHP DualChoice deben cumplir estándares mínimos para las prácticas de farmacia según lo establecido por el estado de California.
¿Qué medicamentos recetados cubre IEHP DualChoice?
IEHP DualChoice (HMO D-SNP) tiene una lista de medicamentos cubiertos o formulario. Dice qué medicamentos recetados de la Parte D están cubiertos por IEHP DualChoice. El plan seleccionó los medicamentos en esta lista con la ayuda de un equipo de doctores y farmacéuticos. La lista debe cumplir los requisitos que estableció Medicare. Medicare ha aprobado la lista de medicamentos cubiertos de IEHP DualChoice.
Encuentre un medicamento cubierto abajo:
Lista de medicamentos cubiertos de 2023 (PDF)
Cambios a lista de medicamentos cubiertos (PDF)
Terapia Escalonada de 2023 (PDF)
Medicamentos que Requieren Autorización Previa de 2023 (PDF)
¿Con qué farmacias tiene contrato IEHP DualChoice?
Nuestro Directorio de Proveedores y Farmacias de IEHP DualChoice (HMO D-SNP) le da una lista completa de las farmacias de nuestra red; eso significa todas las farmacias que han aceptado surtir recetas cubiertas para los miembros de nuestro plan.
Normalmente, debe recibir toda su atención de rutina de proveedores del plan y farmacias de la red para acceder a sus beneficios de medicamentos recetados, excepto en circunstancias que no son de rutina; se pueden aplicar restricciones y limitaciones de cantidad.
Esta no es una lista completa. La información de beneficios es un breve resumen, no una descripción completa de los beneficios. Es posible que se apliquen limitaciones, copagos y restricciones. Los copagos por medicamentos recetados pueden variar según el nivel de ayuda adicional que usted reciba. Los beneficios y copagos pueden modificarse a partir del 1 de enero de cada año. La lista de medicamentos cubiertos y redes de farmacias y proveedores puede modificarse a lo largo del año. Le enviaremos un aviso antes de que hagamos un cambio que lo afecte. Para obtener más información, llame a Servicios para Miembros de IEHP DualChoice o lea el Manual para Miembros de IEHP DualChoice.
Directorio de Proveedores y Farmacias de IEHP DualChoice de 2023 (PDF)
Necesitará Adobe Acrobat Reader 6.0 o una versión superior para ver los archivos en formato PDF. Puede descargar una copia gratuita aquí. Haciendo clic en este enlace, saldrá del sitio web de IEHP DualChoice.
Si no tiene el Directorio de Proveedores y Farmacias de IEHP DualChoice, puede obtener una copia de Servicios para Miembros de IEHP DualChoice. En cualquier momento, puede llamar a Servicios para Miembros de IEHP DualChoice para obtener información actualizada sobre las modificaciones en la red de farmacias. Llame a IEHP DualChoice al 1-877-273-IEHP (4347), 8am – 8pm (hora del Pacífico), los 7 días de la semana, incluyendo los feriados. Los usuarios de TTY deben llamar al 1-800-718-4347.
Cobertura fuera de la red
Normalmente, IEHP DualChoice (HMO D-SNP) cubrirá medicamentos surtidos en una farmacia fuera de la red solamente cuando no pueda usar una farmacia de la red. Estas son las circunstancias en las que cubriríamos recetas surtidas en una farmacia fuera de la red:
¿Qué pasa si necesito un medicamento con receta debido a una emergencia médica?
Cubriremos recetas que se surtan en una farmacia fuera de la red si los medicamentos con receta están relacionados con la atención por una emergencia médica o atención de urgencia. En esta situación, tendrá que pagar el costo total (en lugar de pagar solo el copago) cuando surta su receta médica. Puede pedirnos que le demos un reembolso por nuestra parte del costo presentando un formulario de reclamo en papel. Para saber cómo presentar un reclamo en papel, consulte el proceso de reclamos en papel que se describe abajo.
Cómo obtener cobertura cuando está de viaje o fuera del área de servicio del Plan
Si toma un medicamento recetado de manera regular y se irá de viaje, asegúrese de verificar su suministro del medicamento antes de irse. Cuando sea posible, llévese todos los medicamentos que necesitará. Es posible que pueda pedir sus medicamentos recetados con antelación mediante nuestras farmacias de la red con servicio de entrega por correo o mediante una farmacia de la red local que ofrezca un suministro mayor.
Si va a viajar dentro de los Estados Unidos, pero fuera del área de servicio del Plan y enferma o pierde o se le acaban sus medicamentos recetados, cubriremos recetas que se surtan en una farmacia fuera de la red si sigue todas las demás normas de cobertura identificadas en este documento y si no hay una farmacia de la red disponible. En esta situación, tendrá que pagar el costo total (en lugar de pagar solo el copago) cuando surta su receta médica. Puede pedirnos que le demos un reembolso por nuestra parte del costo presentando un formulario de reclamo. Para saber cómo presentar un reclamo en papel, consulte el proceso de reclamos en papel que se describe abajo.
Antes de surtir su receta en una farmacia fuera de la red, llame a Servicios para Miembros de IEHP DualChoice para saber si hay una farmacia de la red en el área en la que está viajando. Si no hay farmacias de la red en esa área, es posible que los Servicios para Miembros de IEHP DualChoice puedan hacer arreglos para que usted obtenga sus medicamentos recetados de una farmacia fuera de la red.
No podemos pagar ninguna receta que se surta en farmacias fuera de los Estados Unidos, ni siquiera en el caso de una emergencia médica.
¿Qué sucede si está fuera del área de servicio del plan cuando tiene una necesidad urgente de atención médica?
Cuando esté fuera del área de servicio y no puede recibir atención médica de un proveedor de la red, nuestro plan cubrirá la atención médica que necesite con urgencia y que reciba de cualquier proveedor. Nuestro plan no cubre la atención médica que necesite con urgencia ni cualquier otra atención médica si la recibe fuera de los Estados Unidos.
Hay otras ocasiones en las que se pueden cubrir sus medicamentos recetados si va a una farmacia fuera de la red.
Cubriremos sus medicamentos recetados en una farmacia fuera de la red si se da al menos una de las siguientes situaciones:
Si no puede obtener un medicamento cubierto oportunamente dentro de nuestra área de servicio porque no hay farmacias de la red a una distancia razonable con servicio las 24 horas del día.
Si está tratando de surtir un medicamento recetado que está cubierto y no está regularmente en stock en una farmacia local o farmacia con servicio de entrega por correo elegible de la red (estos medicamentos incluyen medicamentos huérfanos u otros productos farmacéuticos especializados). En estas situaciones, consulte primero con Servicios para Miembros de IEHP DualChoice para ver si hay una farmacia de la red cerca.
¿Cómo pide un reembolso del plan?
Si debe usar una farmacia fuera de la red, normalmente tendrá que pagar el costo total (en lugar de pagar su parte habitual del costo compartido) cuando surta su receta. Puede pedirnos que le demos un reembolso por la parte de IEHP DualChoice del costo compartido. Envíenos su solicitud de pago, junto con su factura y documentación de cualquier pago que haya hecho. Es una buena idea hacer copias de su factura y recibos para guardarlas en su archivo. Envíenos por correo su solicitud de pago junto con cualquier factura o recibo que tenga a esta dirección:
IEHP DualChoice
P.O. Box 4259
Rancho Cucamonga, CA 91729-4259
Debe enviarnos su reclamo en un plazo de un año después de la fecha en que recibió el servicio, artículo o medicamento. Asegúrese de comunicarse con Servicios para Miembros de IEHP DualChoice si tiene alguna pregunta. Si no sabe cuánto debería haber pagado, o si recibe facturas y no sabe qué hacer con ellas, podemos ayudarlo. También puede llamar si quiere que le demos más información sobre una solicitud de pago que ya nos ha enviado. Consulte los Capítulos 7 y 9 del Manual para Miembros de IEHP DualChoice para saber cómo pedirle al plan un reembolso.
Modificaciones a la lista de medicamentos cubiertos de IEHP DualChoice
La lista de medicamentos cubiertos de IEHP DualChoice consta de medicamentos que se consideran terapias de primera línea (medicamentos que deberían usarse primero para las afecciones indicadas). IEHP DualChoice desarrolla y mantiene la lista de medicamentos cubiertos constantemente revisando la eficacia (qué tan efectivos son) y la seguridad (qué tan seguros son) de los nuevos medicamentos, compara nuevos medicamentos con medicamentos existentes y genera directrices de prácticas clínicas basadas en la evidencia clínica.
De vez en cuando (durante el año de beneficios), IEHP DualChoice modifica (agregando o quitando medicamentos) la lista de medicamentos cubiertos según nueva evidencia clínica y disponibilidad de productos en el mercado. Un grupo selecto de Proveedores y Farmacéuticos que están actualmente en actividad revisan y aprueban todas las modificaciones.
IEHP DualChoice avisará a los Miembros de IEHP DualChoice antes de quitar medicamentos de la Parte D de la lista de medicamentos cubiertos de la Parte D. También avisaremos si hay alguna modificación sobre autorizaciones previas, límites de cantidad, terapia escalonada o traspaso de un medicamento a un nivel más alto de costos compartidos.
Si IEHP DualChoice quita un medicamento cubierto de la Parte D o hace alguna modificación en la lista de medicamentos cubiertos de IEHP DualChoice, publicaremos las modificaciones de la lista de medicamentos cubiertos en el sitio web de IEHP DualChoice y avisaremos a los Miembros afectados al menos treinta (30) días antes de la fecha de vigencia de la modificación hecha en la lista de medicamentos cubiertos de IEHP DualChoice. Sin embargo, si la Administración de Alimentos y Medicamentos (FDA) considera que un medicamento en nuestra lista de medicamentos cubiertos no es seguro o el fabricante del medicamento saca el medicamento del mercado, quitaremos el medicamento de inmediato de nuestra lista de medicamentos cubiertos.
Algunas modificaciones en la Lista de Medicamentos se producirán de inmediato. Por ejemplo:
Está disponible un nuevo medicamento genérico. A veces, aparece un nuevo medicamento más barato que funciona tan bien como un medicamento que está en la Lista de Medicamentos actualmente. Cuando eso sucede, es posible que quitemos el medicamento actual, pero su costo para el nuevo medicamento seguirá siendo el mismo o será inferior. Cuando agreguemos el nuevo medicamento genérico, es posible que también decidamos mantener el medicamento actual en la lista pero modificar sus normas o límites de cobertura.
Es posible que no le avisemos antes de hacer esta modificación, pero le enviaremos información sobre la modificación o modificaciones específicas que hayamos hecho.
Usted o su proveedor pueden solicitar una “excepción” de estas modificaciones. Le enviaremos un aviso con los pasos que puede tomar para solicitar una excepción. Consulte el Capítulo 9 (Qué hacer si tiene un problema o queja [decisiones de cobertura, apelaciones, quejas]) del Manual para Miembros para obtener más información sobre excepciones.
Sacan del mercado un medicamento. Si la Administración de Alimentos y Medicamentos (FDA) dice que un medicamento que usted está tomando no es seguro o el fabricante del medicamento lo saca del mercado, lo quitaremos de la Lista de Medicamentos. Si está tomando el medicamento, se lo informaremos. Su proveedor también tendrá conocimiento de esta modificación. Podrá trabajar con usted para encontrar otro medicamento para su afección.
Es posible que hagamos otras modificaciones que afecten a los medicamentos que usted toma.
Lo informaremos con antelación de estas otras modificaciones en la Lista de Medicamentos. Estas modificaciones podrían producirse si:
La FDA da nuevas recomendaciones o hay nuevas directrices clínicas sobre un medicamento.
Agregamos un medicamento genérico que no es nuevo en el mercado y:
reemplazamos un medicamento de marca que está actualmente en la Lista de Medicamentos; o
modificamos las normas o límites de cobertura para el medicamento de marca.
Cuando se produzcan estas modificaciones, le avisaremos al menos 30 días antes de que hagamos la modificación en la Lista de Medicamentos o cuando pida volver a surtirlo. Esto le dará tiempo para hablar con su doctor u otro profesional que emite la receta médica. Él o ella podrá ayudarlo a decidir si hay un medicamento similar en la Lista de Medicamentos que pueda tomar en su lugar o si debe solicitar una excepción. Entonces podrá:
obtener un suministro para 31 días del medicamento antes de que se haga la modificación; o
solicitar una excepción de estas modificaciones. Para obtener más información sobre la solicitud de excepciones, consulte el Capítulo 9 (Qué hacer si tiene un problema o queja [decisiones de cobertura, apelaciones, quejas]).
Si sacan repentinamente un medicamento del mercado porque se determinó que no es seguro o por otros motivos, el plan quitará de inmediato el medicamento de la lista de medicamentos cubiertos. Lo informaremos de esta modificación de inmediato.
Su doctor también tendrá conocimiento de esta modificación y podrá trabajar con usted para encontrar otro medicamento para su afección.
¿Cómo se enterará si se ha modificado su cobertura de medicamentos?
Si IEHP DualChoice quita un medicamento cubierto de la Parte D o hace alguna modificación en la lista de medicamentos cubiertos de IEHP DualChoice, IEHP DualChoice publicará las modificaciones de la lista de medicamentos cubiertos en el sitio web de IEHP DualChoice y avisará a los Miembros afectados al menos treinta (30) días antes de la fecha de vigencia de la modificación hecha en la lista de medicamentos cubiertos de IEHP DualChoice. Sin embargo, si la Administración de Alimentos y Medicamentos (FDA) considera que un medicamento en nuestra lista de medicamentos cubiertos no es seguro o el fabricante del medicamento saca el medicamento del mercado, quitaremos el medicamento de inmediato de nuestra lista de medicamentos cubiertos.
Cómo obtener aprobación del Plan
Para determinados medicamentos, usted o su proveedor tienen que obtener aprobación del plan antes de que aceptemos cubrir el medicamento para usted. Esto se llama "autorización previa". A veces el requisito para obtener la aprobación con antelación ayuda a guiar el consumo apropiado de determinados medicamentos. Si no obtiene esta aprobación, el plan podría no cubrir su medicamento. Para obtener más información sobre la terapia escalonada y los límites de cantidad, consulte el Capítulo 5 del Manual para Miembros de IEHP DualChoice. Use el Formulario de Determinación de Cobertura de Medicamentos Recetados de Medicare de IEHP para obtener una autorización previa.
Solicitud de Determinación de Cobertura de Medicamentos Recetados de Medicare (PDF)
Instrucciones para el formulario modelo
Estos formularios también están disponibles en el sitio web de los CMS:
Formulario de Solicitud de Determinación de Medicamentos Recetados de Medicare (para uso de afiliados y proveedores).
Haciendo clic en este enlace, saldrá del sitio web de IEHP DualChoice.
Condiciones y limitaciones aplicables
Normalmente cubriremos un medicamento en la lista de medicamentos cubiertos del plan siempre y cuando siga las demás normas de cobertura que se explican en el Capítulo 6 del Manual para Miembros de IEHP DualChoice y si el medicamento es médicamente necesario, es decir razonable y necesario para el tratamiento de su lesión o enfermedad. Además tiene que ser un tratamiento aceptado para su afección médica.
Estas son tres normas generales sobre medicamentos que los planes de medicamentos de Medicare no cubrirán en la Parte D:
La cobertura de medicamentos de la Parte D de nuestro plan no puede cubrir un medicamento que estaría cubierto por Medicare Parte A o Parte B.
Nuestro plan no puede cubrir un medicamento comprado fuera de los Estados Unidos y sus territorios.
Nuestro plan normalmente no puede cubrir la administración para una indicación no autorizada. La “administración para indicaciones no autorizadas” es cualquier administración del medicamento que no sea una indicación del medicamento aprobada por la Administración de Alimentos y Medicamentos.
Para obtener más información, consulte el Capítulo 6 de su Manual para Miembros de IEHP DualChoice.
Cómo obtener un suministro temporal
En algunos casos, podemos darle un suministro temporal de un medicamento cuando el medicamento no esté en la lista de medicamentos o cuando esté limitado de alguna manera. Esto le da tiempo para hablar con su proveedor de obtener un medicamento diferente o solicitarnos que cubramos el medicamento.
Para obtener un suministro temporal de un medicamento, debe cumplir las dos normas que se indican abajo:
El medicamento que ha estado tomando:
ya no está en nuestra lista de medicamentos; o
nunca estuvo en nuestra lista de medicamentos; o
ahora está limitado de alguna manera.
Debe estar en alguna de estas situaciones:
Estaba en el plan el año pasado.
Es nuevo en nuestro plan.
Ha estado en el plan por más de 90 días y vive en un centro médico de atención a largo plazo y necesita un suministro de inmediato.
Cuando obtenga un suministro temporal de un medicamento, debe hablar con su proveedor para decidir qué hacer cuando se acabe su suministro. Estas son sus opciones:
Puede cambiar a otro medicamento.
Es posible que haya un medicamento diferente cubierto por nuestro plan y que funcione para usted. Puede llamar a Servicios para Miembros para pedir una lista de medicamentos cubierto que tratan la misma afección médica. La lista puede ayudar a su proveedor a encontrar un medicamento cubierto que pueda funcionar para usted.
O
Puede solicitar una excepción.
Usted y su proveedor pueden solicitarnos que hagamos una excepción. Por ejemplo, puede pedirnos que cubramos un medicamento aunque no se esté en la lista de medicamentos. O puede pedirnos que cubramos el medicamento sin límites. Si su proveedor dice que tiene un buen motivo médico para obtener una excepción, él o ella puede ayudarlo a solicitarla.
Si un medicamento que usted está tomando se quitará de la lista de medicamentos o se limitará de alguna manera para el próximo año, le permitiremos solicitar una excepción antes del próximo año.
Lo informaremos de cualquier modificación en la cobertura de su medicamento para el próximo año. Luego puede solicitarnos que hagamos una excepción y cubramos el medicamento de la manera en que usted quiere que lo cubramos para el próximo año.
Responderemos a su solicitud de una excepción en un plazo de 72 horas después de recibir su solicitud (o la declaración de apoyo del profesional que emite su receta médica).
Aviso de cobertura de medicamentos recetados de Medicare y sus derechos - Publicación de los derechos de cobertura de medicamentos de los miembros:
Medicare requiere que las farmacias les den un aviso a los afiliados cada vez que se le niega la cobertura a un miembro o no están de acuerdo con la información sobre costos compartidos.
Usted tiene derecho a apelar o solicitar una excepción de la lista de medicamentos cubiertos si no está de acuerdo con la información que le dio el farmacéutico. Lea sus derechos de cobertura de medicamentos de los miembros de Medicare.
Control del uso de los medicamentos
Hacemos revisiones del uso de medicamentos para asegurarnos de que nuestros miembros estén recibiendo una atención médica segura y apropiada. Estas revisiones son especialmente importantes para miembros que tienen más de un proveedor que les receta sus medicamentos.
IEHP DualChoice (HMO D-SNP) tiene un proceso implementado para identificar y reducir errores de medicación. Hacemos una revisión cada vez que surte una receta. También revisamos nuestros expedientes con regularidad. Durante estas revisiones, buscamos potenciales problemas como:
Posibles errores de medicación.
Medicamentos que es posible que no sean necesarios porque está tomando otro medicamento para tratar la misma afección.
Medicamentos que es posible que no sean seguros o apropiados debido a su edad o género.
Determinadas combinaciones de medicamentos que podrían causarle daño si se toman a la vez.
Recetas de medicamentos que tienen ingredientes a los que usted es alérgico.
Posibles errores en la cantidad (dosis) o duración de un medicamento que está tomando.
Administración excesiva e insuficiente.
Uso indebido/abuso clínico.
Si detectamos un posible problema en su uso de medicamentos, trabajaremos con su Doctor para corregir el problema. IEHP DualChoice también ofrece información a los Centros de Servicios de Medicare y Medicaid (CMS) sobre sus medidas de aseguramiento de calidad según las directrices que especificaron los CMS.
La información de esta página está vigente desde el 01 de octubre de 2022
DSNP_23_3241532_M
Ultimas noticias - IEHP promueve el equilibrio con actividades para los jóvenes
venes enfrentan en la escuela, y con su familia y amigos, Inland Empire Health Plan (IEHP) ofrece un programa regular de clases divertidas – y gratuitas – en sus centros de recursos para la comunidad. “Las actividades extracurriculares disminuyen el potencial de conductas riesgosas en los niños y los adultos jóvenes y los hacen sentir más conectados y que tienen un lugar en el mundo”, dijo Amrita Rai, Directora de IEHP de Salud Clínica del Comportamiento. “Cualquier tipo de oportunidad de participar en actividades que apoyen el desarrollo emocional saludable puede aumentar la autoestima y la capacidad de relacionarse con otras personas similares, lo que ofrece beneficios para la edad adulta”. Los Centros de Recursos para la Comunidad IEHP pueden ayudar a promover y mejorar la salud mental de los residentes jóvenes de Inland Empire. Los tres centros en Riverside, San Bernardino y Victorville ofrecen clases y actividades, incluyendo Zumba, artes creativas, cocina y jardinería. Las sesiones se hacen de lunes a sábados y pueden encontrarse en iehp.org. Las recomendaciones del Director del servicio federal de sanidad de los EE. UU. para 2021 destacan aún más el impacto del COVID-19 en la crisis actual de salud mental en los jóvenes, citando la necesidad urgente de tratar estos retos sin demora, con medidas coordinadas por organizaciones comunitarias y federales y reconociendo que la salud mental es una parte esencial de la salud general. El concepto no es nuevo para IEHP, que actualmente está asociado con varias organizaciones comunitarias y Agencias Locales de Educación para expandir sus servicios de salud del comportamiento en las escuelas y cerca de ellas (Programa de Incentivo de Salud del Comportamiento para Estudiantes [Student Behavioral Health Incentive Program]). El plan médico también está explorando oportunidades de agregar a sus centros más clases y actividades gratuitas para adolescentes y adultos jóvenes, por medio de una colaboración con Young Visionaries Youth Leadership Academy. “Esperamos poder agregar más diversión a los programas de nuestros centros en las próximas semanas y meses”, dijo Delia Orosco, Gerente del Centro de Recursos para la Comunidad IEHP en Victorville. “Nuestro centro es un espacio seguro para todos los que entren, independientemente de la edad, para expresarse de verdad, y nosotros nos lo tomamos muy seriamente”. Para obtener más información sobre los Centros de Recursos para la Comunidad IEHP y el horario de las clases, visite iehp.org.
MediCal - Proposition 56 & GEMT
2016, now includes proposed supplemental payments for physicians participating in Medi-Cal Fee-For-Service (FFS) and Medi-Cal Managed Care.
Proposition 56 FAQs SFY 19/20 (PDF) Published: February 18, 2020
Click on the following links to jump to that specific section:
Electronic Payments
Ground Emergency Medical Transport (GEMT) Payment
Adverse Childhood Experiences Screening (ACES) Services
HYDE
Developmental Screening Services
Proposition 56 and GEMT Payment Schedule
Family Planning Services
Proposition 56 Payment Dispute Process
Electronic Payments
With the current public health situation that our country is experiencing, it is necessary for IEHP to take additional precautions to ensure the health and well-being of our community. These precautions are being reviewed, and discussed daily, by our Executive leadership team and will be implemented as deemed necessary. Future COVID-19 precautions may include reduced on-site staffing and prioritization of electronic payments over printed checks.
To minimize any disruption or delay in payment, we recommend that you sign up for electronic payments as soon as possible if you have not done so already. Our team is available to assist you with the necessary paperwork required to make this change or to answer any questions you may have. The team can be reached by e-mailing vendormaintenance@iehp.org or by calling (909) 294-3928 and selecting Option 1.
Our priority remains keeping our Members, Providers, Vendors, and Team Members safe while doing what we can to minimize the potential spread of the virus. We will continue to work hard to provide you with the level of service you have come to expect during this uncertain time.
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Adverse Childhood Experiences Screening (ACES) Services
Proposition 56 Adverse Childhood Experience Screening (ACES) Services (PDF) Published: May 15, 2020
FAQs on Proposition 56 Payment - Adverse Childhood Experience Screening (ACES) Services (PDF) Published: October 14, 2021
PSA Videos:
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Resilience
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Developmental Screening Services
Proposition 56 Developmental Screening Services (PDF) Published: March 19, 2020
FAQs on Proposition 56 - Developmental Screening Services (PDF) Published: October 14, 2021
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Family Planning Services
Proposition 56 - Family Planning Services (PDF) Published: June 1, 2022
FAQs on Proposition 56 - Family Planning Screening Services (PDF) Published: October 13, 2022
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Ground Emergency Medical Transport (GEMT) Payment
The Department of Health Care Services (DHCS) has established a Ground Emergency Medical Transport (GEMT) Quality Assurance Fee (QAF) program. In accordance with 42 USC Section 1396u-2(b)(2)(D), Title 42 of the Code of Federal Regulations part 438.114(c), and WIC Sections 14129-14129.7, Medi-Cal Managed Care Health Plans must provide increased reimbursement rates for specified GEMT services to non-contracted GEMT providers. SPA 18-004 implements a one-year QAF program and reimbursement add-on for GEMT provided by emergency medical transportation providers effective for State Fiscal Year (SFY) 2018-19 from July 1, 2018, to June 30, 2019.
GEMT Program Overview (PDF)
FAQs on GEMT (PDF)
GEMT Dispute Request Form (PDF)
Please email completed forms to Prop56Inquiry@iehp.org or fax to (909) 296-3550.
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HYDE
Proposition 56 HYDE Services (PDF) Published: May 15, 2020
FAQs on Proposition 56 - HYDE Services (PDF) Published: October 14, 2021
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Proposition 56 and GEMT Payment Schedule
Proposition 56 and GEMT Supplemental Payment Schedule CY2023 Updated: January 6, 2023
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Proposition 56 Payment Dispute Process
Proposition 56 - Paid Claims Dispute Request Form (PDF)
Proposition 56 - Encounter Dispute Request Form (PDF)
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You will need Adobe Acrobat Reader 6.0 or later to view the PDF files. You can download a free copy by clicking here.
IEHP DualChoice - NCD
edicare and Medical Services, CMS) han determinado que los siguientes servicios son necesarios para el tratamiento de una enfermedad o lesión. Las determinaciones de cobertura nacional (NCD) se hacen mediante un proceso basado en evidencias. Abajo puede encontrar una breve descripción de cada NCD. Es posible que haya calificaciones o restricciones sobre los procedimientos mencionados abajo.
Para obtener más información detallada sobre cada una de las NCD, incluyendo restricciones y calificaciones, haga clic en el enlace después de cada NCD o llame a Servicios para Miembros de IEHP DualChoice al (877) 273-IEHP (4347), 8am – 8pm (hora del Pacífico), los 7 días de la semana, incluyendo feriados, o TTY/TDD (800) 718-4347
1. Prueba de detección de infección por virus de hepatitis B (HBV)
(Entrada en vigor: 28 de septiembre de 2016)
(Fecha de implementación: 2 de octubre de 2017, para diseño y codificación; 1 de enero de 2018, para pruebas e implementación)
Según la recomendación del Grupo de Trabajo de Servicios Preventivos de los Estados Unidos (United States Preventive Services Task Force, USPSTF), los CMS han emitido una determinación de cobertura nacional (NCD) que amplía la cobertura para incluir las pruebas de detección de infección por HBV. Antes, las pruebas de detección de HBV y su repetición solo estaban cubiertas para mujeres embarazadas.
El virus de la hepatitis B (HBV) se transmite por exposición a fluidos corporales. Ataca el hígado y causa inflamación. Las personas infectadas pueden tener síntomas como náuseas, anorexia, cansancio, fiebre y dolor abdominal, o es posible que no tengan síntomas. Una infección aguda por HBV podría avanzar y causar complicaciones potencialmente mortales.
El USPTF ha determinado que las pruebas de detección de HBV permiten la intervención precoz que puede ayudar a disminuir el contagio de la enfermedad y su transmisión y, mediante el tratamiento, mejorar los resultados intermedios para los infectados.
¿Qué está cubierto?
Para los reclamos con fechas de servicio a partir del 09/28/2016, los CMS cubren las pruebas de detección de infección por HBV.
¿Quiénes están cubiertos?
Los beneficiarios de Medicare que cumplan cualquiera de los siguientes criterios:
se considera que tienen un riesgo alto de infección; o
están embarazadas.
Haga clic aquí para obtener más información sobre pruebas de detección de HBV.
2. Descompresión lumbar guiada por imagen percutánea (PILD) por estenosis espinal lumbar (Lumbar Spinal Stenosis, LSS)
(Entrada en vigor: 7 de diciembre de 2016)
(Fecha de implementación: 27 de junio de 2017)
Los CMS han ampliado la determinación de cobertura nacional (NCD) para la PILD por LSS para que ahora cubra a los beneficiarios que están inscritos en un estudio longitudinal prospectivo aprobado por los CMS. Antes, la PILD por LSS estaba cubierta para beneficiarios inscritos solamente en ensayos clínicos controlados (RCT), prospectivos y aleatorizados aprobados por los CMS según el paradigma de cobertura con desarrollo de evidencia (CED). Ahora, la NCD cubrirá la PILD por LSS en los estudios longitudinales y RCT.
La LSS es un estrechamiento del canal espinal en la zona lumbar. La PILD es una descompresión posterior de la columna lumbar con guía por imágenes indirectas, sin ninguna visualización directa del área quirúrgica. En el procedimiento se extirpa una parte de la lámina para quitarle volumen al ligamento amarillo, lo que básicamente amplía el canal espinal en el área afectada.
¿Qué está cubierto?
Para los reclamos con fechas de servicio a partir del 12/07/16, Medicare cubrirá la PILD según la CED para beneficiarios con LSS cuando se haga en un estudio clínico aprobado.
¿Quiénes están cubiertos?
Los beneficiarios de Medicare con LSS que estén participando en un estudio clínico aprobado.
Haga clic aquí para obtener más información sobre evaluaciones mediante PILD por LSS.
3. Marcapasos sin cables
(Entrada en vigor: 18 de enero de 2017)
(Fecha de implementación: 29 de agosto de 2017, para ediciones locales de MAC; 2 de enero de 2018, para ediciones compartidas de MCS)
Los CMS han emitido una determinación de cobertura nacional (NCD) que amplía la cobertura para incluir marcapasos sin cables cuando los procedimientos se hagan en estudios de cobertura con desarrollo de evidencia (CED) aprobados por los CMS.
Los marcapasos sin cables se colocan en el corazón por medio de un catéter, y funcionan del mismo modo que otros marcapasos ventriculares transvenosos de una sola cámara. El marcapasos sin cables elimina la necesidad de un bolsillo para el dispositivo y de la inserción de un electrodo, que son elementos integrales de los sistemas de marcapasos tradicionales. La eliminación de estos elementos quita una importante fuente de complicaciones asociadas a los sistemas de marcapasos tradicionales mientras se dan beneficios similares. Los marcapasos sin cables se colocan en el corazón por medio de un catéter, y funcionan del mismo modo que otros marcapasos ventriculares transvenosos de una sola cámara. Antes del 18 de enero de 2017, no había ninguna determinación de cobertura nacional (NCD) en vigor.
¿Qué está cubierto?
Para los reclamos con fechas de servicio a partir del 01/18/17, Medicare cubrirá los marcapasos sin cables según la CED cuando los procedimientos se hagan en estudios aprobados por los CMS.
¿Quiénes están cubiertos?
Los beneficiarios de Medicare que necesiten un marcapasos y que estén participando en un estudio clínico aprobado.
Haga clic aquí para obtener más información sobre marcapasos sin cables.
4. Oxigenoterapia hiperbárica (HBO) (Inciso C, Aplicación tópica de oxígeno)
(Entrada en vigor: 3 de abril de 2017)
(Fecha de implementación: 18 de diciembre de 2017)
Los CMS han revisado el Capítulo 1, Sección 20.29, Apartado C, Aplicación tópica de oxígeno, para eliminar la exclusión de este tratamiento. Se actualizó para que los contratistas locales pueden determinar la cobertura para la aplicación tópica de oxígeno para el tratamiento de heridas crónicas.
¿Qué está cubierto?
Aplicación tópica de oxígeno para el cuidado de heridas crónicas.
¿Quiénes están cubiertos?
Los beneficiarios de Medicare pueden estar cubiertos con una determinación de cobertura afirmativa.
Haga clic aquí para obtener más información sobre aplicaciones tópicas de oxígeno.
5. Terapia de ejercicios supervisados (SET) para enfermedad arterial periférica (PAD) sintomática
(Entrada en vigor: 25 de mayo de 2017)
(Fecha de implementación: 2 de julio de 2018)
Los CMS han agregado una nueva sección, la Sección 20.35, al Capítulo 1, Terapia de ejercicios supervisados (SET) para enfermedad arterial periférica (PAD) sintomática. Se ha concluido que las investigaciones de alta calidad muestran la eficacia de la SET por sobre opciones de tratamiento más invasivas, y los beneficiarios que sufran de claudicación intermitente (un síntoma frecuente de la PAD) ahora tienen derecho a un tratamiento inicial.
¿Qué está cubierto?
Los beneficiarios elegibles tienen derecho a 36 sesiones en un período de 12 semanas después de reunirse con el médico responsable del tratamiento de la PAD y de recibir una referencia.
El programa de SET debe:
incluir sesiones de 30-60 minutos de un programa de ejercicios terapéuticos/entrenamiento para la PAD;
hacerse en un entorno hospitalario para pacientes ambulatorios o el consultorio del médico;
ser proporcionado por personal auxiliar calificado necesario para asegurar que los beneficios excedan los daños, y capacitado en terapia de ejercicios para la PAD; y
hacerse bajo la supervisión directa de un médico.
¿Quiénes están cubiertos?
Los beneficiarios de Medicare a los que se les haya diagnosticado enfermedad arterial periférica sintomática y que se beneficiarían con esta terapia.
Haga clic aquí para obtener más información sobre la terapia de ejercicios supervisados (SET) para la enfermedad arterial periférica (PAD) sintomática.
6. Imágenes de resonancia magnética (MRI)
(Entrada en vigor: 10 de abril de 2017)
(Fecha de implementación: 10 de diciembre de 2018)
Los CMS han agregado una nueva sección, la Sección 220.2, al Capítulo 1, Parte 4 del Manual de Determinaciones de Cobertura Nacional de Medicare, titulado Imágenes de resonancia magnética (MRI). Según el etiquetado de la FDA en un entorno de MRI, las MRI estarán cubiertas para los beneficiarios en determinadas condiciones.
¿Qué está cubierto?
A partir del 10 de abril de 2018, la MRI estará cubierta cuando se use de acuerdo con el etiquetado de la FDA en un entorno de MRI.
Cuando no haya un etiquetado de la FDA específico para uso en un entorno de MRI, la cobertura solo se proporciona en condiciones específicas, incluyendo las siguientes:
Potencia de campo de MRI de 1.5 Teslas usando el modo de operación normal.
El sistema del marcapasos implantado (PM), desfibrilador cardioversor implantable (ICD), marcapasos para terapia de resincronización cardíaca (CRT-P) y desfibrilador para terapia de resincronización cardíaca (CRT-D) no tiene cables sueltos, fracturados o epicárdicos.
El centro ha implementado una lista de verificación específica.
¿Quiénes están cubiertos?
Beneficiarios de Medicare con un marcapasos implantado (PM), desfibrilador cardioversor implantable (ICD), marcapasos para terapia de resincronización cardíaca (CRT-P) y desfibrilador para terapia de resincronización cardíaca (CRT-D).
Haga clic aquí para obtener más información sobre la cobertura de MRI.
7. Desfibriladores cardíacos implantables (ICD)
(Entrada en vigor: 15 de febrero de 2018)
(Fecha de implementación: 26 de marzo de 2019)
Los CMS han actualizado el Capítulo 1, Parte 1, Sección 20.4 del Manual de Determinaciones de Cobertura Nacional de Medicare para agregar criterios de cobertura de desfibriladores cardíacos implantables (ICD) para las taquiarritmias ventriculares (VT).
¿Qué está cubierto?
Un ICD es un dispositivo electrónico para diagnosticar y tratar taquiarritmias ventriculares (VT) potencialmente mortales, que ha demostrado una mejora en las tasas de supervivencia y reducción de las muertes por problemas del corazón en determinados pacientes. Los Centros de Servicios de Medicare y Medicaid (Centers for Medicare and Medical Services, CMS) cubrirán reclamos con fechas de servicio efectivas del 15 de febrero de 2018 o posteriores.
¿Quiénes están cubiertos?
Los beneficiarios que cumplan los criterios de cobertura, si se determina que son elegibles.
Se cubrirán los ICD para pacientes con las siguientes indicaciones:
historia personal de VT sostenida o paro cardíaco debido a fibrilación ventricular (VF);
infarto de miocardio (MI) previo y fracción de eyección del ventrículo izquierdo (LVEF) medida igual o inferior a 0.03;
miocardiopatía isquémica dilatada grave sin historia de VT sostenida ni paro cardíaco debido a VF, e insuficiencia cardíaca de clase II o III de la New York Heart Association (NYHA) con una LVEF igual o inferior a 35 %;
miocardiopatía no isquémica dilatada grave, sin historia de paro cardíaco ni VT sostenida, insuficiencia cardíaca de clase II o III de la NYHA, LVEF igual o inferior a 35 % y uso de terapia médica óptima durante un mínimo de tres (3) meses;
trastornos genéticos o familiares documentados con un alto riesgo de taquiarritmias potencialmente mortales, pero no solo síndrome del QT largo o miocardiopatía hipertrófica;
ICD existente que se deba reemplazar debido a la duración de la batería, indicador de reemplazo electivo (ERI) o funcionamiento defectuoso.
Consulte la sección 20.4 del Manual de NCD para conocer los criterios de cobertura adicionales.
Haga clic aquí para obtener más información sobre la cobertura de ICD.
8. Secuenciación de nueva generación (Next Generation Sequencing, NGS) para beneficiarios de Medicare con cáncer de la línea germinal (hereditario)
(Entrada en vigor: 27 de enero de 2020)
(Fecha de implementación: 13 de noviembre de 2020)
Los CMS han actualizado el Capítulo 1, Parte 2, Sección 90.2 del Manual de Determinaciones de Cobertura Nacional de Medicare para incluir pruebas de NGS para cáncer de la línea germinal (hereditario) cuando se cumplan requisitos específicos, y han actualizado los criterios para la cobertura del cáncer somático (adquirido).
¿Qué está cubierto?
Para las fechas de servicio a partir del 27 de enero de 2020, los CMS han determinado que la NGS, como análisis de laboratorio de diagnóstico, es razonable y necesaria, y se cubre a nivel nacional para pacientes con cáncer de la línea germinal (hereditario) cuando se hace en un laboratorio con certificación según la CLIA, cuando lo ordena un médico tratante y cuando se cumplen requisitos específicos.
¿Quiénes están cubiertos?
Beneficiarios con cáncer somático (adquirido) o cáncer de la línea germinal (hereditario) cuando se hace en un laboratorio con certificación de las Enmiendas a la Ley de Mejoramiento de Laboratorios Clínicos (CLIA), cuando lo ordena un médico tratante y cuando se cumplen todos los siguientes requisitos:
Para cáncer somático (adquirido):
El beneficiario:
tiene cáncer recurrente, recidivante, refractario, metastásico o en estado avanzado III o IV;
no se ha hecho antes la misma prueba usando NGS para el mismo contenido genético de cáncer; y
ha decidido recibir un tratamiento adicional para el cáncer (p. ej., quimioterapia terapéutica).
El análisis de laboratorio de diagnóstico que usa NGS debe:
tener la aprobación o autorización de la Administración de Alimentos y Medicamentos (FDA) como diagnóstico in vitro complementario;
tener indicación aprobada o autorizada por la FDA para su uso en el cáncer de ese paciente; y
darle los resultados al médico tratante para control del paciente usando una plantilla de reporte para especificar las opciones de tratamiento.
Para cáncer de la línea germinal (hereditario):
El beneficiario:
-
tiene una indicación clínica para pruebas de cáncer de la línea germinal (hereditario) por cáncer hereditario de los senos o de los ovarios;
tiene un factor de riesgo para cáncer de los senos o de los ovarios de la línea germinal (hereditario); y
-no se ha hecho antes la misma prueba de la línea germinal usando NGS para el mismo contenido genético de la línea germinal.
El análisis de laboratorio de diagnóstico que usa NGS debe:
tener aprobación o autorización de la FDA; y
darle los resultados al médico tratante para control del paciente usando una plantilla de reporte para especificar las opciones de tratamiento.
Los contratistas administrativos de Medicare (MAC) pueden determinar la cobertura de la NGS como un examen de diagnóstico cuando se cumplan criterios específicos adicionales.
Haga clic aquí para obtener información sobre la cobertura de la secuenciación de nueva generación.
9. Angioplastía transluminal percutánea (PTA)
(Entrada en vigor: 19 de febrero de 2019)
(Fecha de implementación: 19 de febrero de 2019)
Los CMS han actualizado el Capítulo 1, Parte 1, Sección 20.7 del Manual de Determinaciones de Cobertura Nacional de Medicare para agregar información sobre la PTA.
¿Qué está cubierto?
La angioplastía transluminal percutánea (PTA) se cubre en los casos de abajo para mejorar el flujo de sangre a través del segmento enfermo de un vaso para dilatar lesiones de arterias periféricas, renales y coronarias.
¿Quiénes están cubiertos?
La PTA se cubre en las siguientes condiciones:
1. tratamiento de lesiones obstructivas por arterosclerosis;
2. concurrente con la colocación de un stent en la carótida en ensayos clínicos con exención para dispositivos en investigación (IDE) de categoría B aprobados por la Administración de Alimentos y Medicamentos (FDA);
3. concurrente con la colocación de un stent en la carótida en estudios posteriores a la aprobación y aprobados por la FDA;
4. concurrente con la colocación de un stent en la carótida en pacientes con alto riesgo de endarterectomía carotídea (CEA);
5. concurrente con la colocación de un stent intracraneal en ensayos clínicos con IDE de categoría B y aprobados por la FDA.
Haga clic aquí para obtener más información sobre la cobertura de la PTA.
10. Reemplazo de la válvula aórtica transcatéter (TAVR)
(Entrada en vigor: 21 de junio de 2019)
(Fecha de implementación: 12 de junio de 2020)
Los CMS han actualizado el Capítulo 1, Sección 20.32 del Manual de Determinaciones de Cobertura Nacional de Medicare. Los Centros de Servicios de Medicare y Medicaid (Centers for Medicare and Medical Services, CMS) cubrirán el reemplazo de la válvula aórtica transcatéter (transcatheter aortic valve replacement, TAVR) según la cobertura con desarrollo de evidencia (CED), cuando se cumplan requisitos específicos.
¿Qué está cubierto?
A partir del 21 de junio de 2019, los CMS cubrirán el TAVR según la CED cuando el procedimiento esté relacionado con el tratamiento de la estenosis sintomática de la válvula aórtica y de acuerdo con la indicación aprobada por la Administración de Alimentos y Medicamentos (FDA) para su uso con un dispositivo aprobado, o en estudios clínicos cuando se cumplan los criterios, además de los criterios de cobertura que se describen en el Manual de NCD.
¿Quiénes están cubiertos?
Este servicio se cubrirá cuando el TAVR se use para el tratamiento de la estenosis sintomática de la válvula aórtica de acuerdo con las indicaciones aprobadas por la FDA y se cumplan las siguientes condiciones:
La FDA aprobó la solicitud de comercialización (PMA) del procedimiento y el sistema de implantación para la indicación aprobada por la FDA para ese sistema.
El paciente está bajo el cuidado de un equipo de atención cardíaca formado por un cirujano cardíaco, un cardiólogo intervencionista y diversos proveedores, enfermeros y personal de investigación.
El cardiólogo intervencionista y el cirujano cardíaco del equipo deben trabajar juntos en los aspectos relacionados del TAVR.
El hospital donde se haga el TAVR debe tener diversas calificaciones y programas implementados.
El registro deberá recoger los datos necesarios y tener un plan de análisis por escrito para tratar diversas cuestiones.
Este servicio se cubrirá cuando el TAVR no se incluya expresamente como una indicación aprobada por la FDA, pero cuando se haga dentro de un estudio clínico y se cumplan las siguientes condiciones:
El cardiólogo intervencionista y el cirujano cardíaco del equipo deben trabajar juntos en los aspectos relacionados del TAVR.
El estudio de investigación clínica debe evaluar críticamente la calidad de vida de cada paciente antes y después del TAVR durante 1 año como mínimo, pero también debe tratar otras cuestiones.
El estudio clínico debe cumplir todos los estándares de integridad científica y relevancia para la población de Medicare.
Haga clic aquí para obtener más información sobre la cobertura de la NGS.
11. Monitoreo ambulatorio de presión arterial (ABPM)
(Entrada en vigor: 2 de julio de 2019)
(Fecha de implementación: 16 de junio de 2020)
Los CMS han actualizado el Capítulo 1, Sección 20.19 del Manual de Determinaciones de Cobertura Nacional de Medicare. Los Centros de Servicios de Medicare y Medicaid (Centers for Medicare and Medical Services, CMS) cubrirán el monitoreo ambulatorio de presión arterial (ABPM) cuando se cumplan requisitos específicos.
¿Qué está cubierto?
A partir del 2 de julio de 2019, los CMS cubrirán el monitoreo ambulatorio de presión arterial (ABPM) cuando se sospeche que los beneficiarios tienen hipertensión de bata blanca o hipertensión enmascarada además de los criterios de cobertura que se describen en el Manual de NCD.
¿Quiénes están cubiertos?
Este servicio se cubrirá cuando el monitoreo ambulatorio de presión arterial (ABPM) se use para diagnosticar hipertensión cuando se sospecha hipertensión de bata blanca o hipertensión enmascarada y se cumplan las siguientes condiciones:
El dispositivo de ABPM debe:
ser capaz de producir gráficos estandarizados de mediciones de presión arterial durante 24 horas con demarcación de ventanas de día y noche y de bandas de presión;
entregarse a los pacientes con instrucciones verbales y escritas, y se debe hacer una prueba de funcionamiento en el consultorio del médico; y
ser interpretado por el médico tratante o un proveedor de asistencia médica tratante que no sea médico.
La cobertura de otras indicaciones para el ABPM queda a discreción de los contratistas administrativos de Medicare.
Haga clic aquí para obtener más información sobre la cobertura del monitoreo ambulatorio de presión arterial.
12. Acupuntura para lumbalgia crónica (cLBP)
(Entrada en vigor: 21 de enero de 2020)
(Fecha de implementación: 5 de octubre de 2020)
Los CMS han actualizado el Capítulo 1, Sección 30.3.3 del Manual de Determinaciones de Cobertura Nacional de Medicare. Los Centros de Servicios de Medicare y Medicaid (Centers for Medicare and Medical Services, CMS) cubrirán la acupuntura para lumbalgia crónica (cLBP) cuando se cumplan requisitos específicos.
¿Qué está cubierto?
A partir del 21 de enero de 2020, los CMS cubrirán la acupuntura para lumbalgia crónica (cLBP) por hasta 12 visitas en 90 días y 8 sesiones adicionales para los beneficiarios que muestren una mejora, además de los criterios de cobertura que se describen en el Manual de NCD.
¿Quiénes están cubiertos?
Este servicio se cubrirá solamente para beneficiarios a los que les diagnostiquen lumbalgia crónica (cLBP) cuando se cumplan las siguientes condiciones:
Para tomar esta decisión, la cLBP:
dura 12 semanas o más;
es inespecífica, sin una causa sistémica identificable (es decir, no está asociada a una enfermedad metastásica, inflamatoria, infecciosa, etc.);
no está asociada a una cirugía; y
no está asociada al embarazo.
Se cubrirán 8 sesiones adicionales para pacientes que muestren una mejora.
No se podrán administrar más de 20 tratamientos de acupuntura al año.
Se deben suspender los tratamientos si el paciente no mejora o tiene un retroceso.
Ningún tipo de acupuntura por cualquier condición que no sea la cLBP está cubierto por Medicare, incluyendo la punción seca.
Haga clic aquí para obtener más información sobre la cobertura de acupuntura para la lumbalgia crónica.
13. Estimulación del nervio vago (VNS)
(Entrada en vigor: 15 de febrero de 2020)
(Fecha de implementación: 22 de julio de 2020)
Los CMS han actualizado el Capítulo 1, Sección 160.18 del Manual de Determinaciones de Cobertura Nacional de Medicare. Los Centros de Servicios de Medicare y Medicaid (Centers for Medicare and Medical Services, CMS) cubrirán la estimulación del nervio vago (Vagus Nerve Stimulation, VNS) para la depresión resistente al tratamiento cuando se cumplan requisitos específicos.
¿Qué está cubierto?
A partir del 15 de febrero de 2020, los CMS cubrirá dispositivos de estimulación del nervio vago (VNS) aprobados por la FDA para la depresión resistente al tratamiento mediante la cobertura con desarrollo de evidencia (CED) en ensayos clínicos aprobados por los CMS, además de los criterios de cobertura que se describen en el Manual de Determinaciones de Cobertura Nacional.
¿Quiénes están cubiertos?
Los beneficiarios que participen en estudios clínicos aprobados por los CMS, que reciban estimulación del nervio vago (VNS) para la depresión resistente al tratamiento y que cumplan los siguientes requisitos:
El tratamiento se administra como parte de un ensayo aprobado por los CMS mediante la cobertura con desarrollo de evidencia (CED). Se pueden encontrar los criterios de ensayo clínico detallados en la sección 160.18 del Manual de Determinaciones de Cobertura Nacional.
El estudio clínico debe ocuparse de determinar si el tratamiento con VNS mejora los resultados médicos para la depresión resistente al tratamiento comparado con un grupo de control, respondiendo todas las preguntas de investigación que se incluyen en la sección 160.18 del Manual de Determinaciones de Cobertura Nacional.
Criterios para los pacientes:
Se deben usar los siguientes criterios para identificar a un beneficiario que tiene depresión resistente al tratamiento:
El beneficiario debe estar en un episodio depresivo mayor por al menos dos años o haber tenido al menos cuatro episodios, incluyendo el episodio actual.
La enfermedad depresiva del paciente cumple un criterio mínimo de cuatro tratamientos previos fallidos con dosis y duración adecuadas según medición con una herramienta diseñada para este fin.
El paciente tiene un episodio depresivo mayor, según la medición con una escala de evaluación de la depresión recomendada por directrices recomendada en dos visitas en un plazo de 45 días antes de la implantación del dispositivo de VNS.
Los pacientes deben mantener un régimen de medicación estable durante al menos cuatro semanas antes de la implantación del dispositivo.
Si se incluyen pacientes con trastorno bipolar, la enfermedad debe caracterizarse con cuidado.
Los pacientes no deben tener:
una historia de características psicóticas en ningún MDE, ni actualmente;
una historia de esquizofrenia ni trastorno esquizoafectivo, ni actualmente;
una historia de cualquier otro trastorno psicótico, ni actualmente;
una historia de trastorno bipolar de ciclo rápido, ni actualmente;
un diagnóstico secundario actual de delirio, demencia, amnesia u otro trastorno cognitivo;
intención suicida actual;
tratamiento con otro dispositivo en investigación o medicamentos en investigación.
Los CMS revisan los estudios para determinar si cumplen los criterios mencionados en la Sección 160.18 del Manual de Determinaciones de Cobertura Nacional.
Indicaciones no cubiertas a nivel nacional
La VNS no está cubierta para el tratamiento de TRD cuando se administra fuera de un estudio de CED aprobado por los CMS.
Todas las demás indicaciones de la VNS para el tratamiento de la depresión no están cubiertas a nivel nacional.
Los pacientes que tengan implantado un dispositivo de VNS por TRD pueden recibir un reemplazo del dispositivo de VNS si es necesario debido al agotamiento de la vida de la batería o cualquier funcionamiento defectuoso relacionado con el dispositivo.
Haga clic aquí para obtener más información sobre la estimulación del nervio vago.
14. Terapia con linfocitos T con receptores quiméricos de antígenos (Chimeric Antigen Receptor, CAR)
(Entrada en vigor: 7 de agosto de 2019)
(Fecha de implementación: 20 de septiembre de 2021)
Los CMS han actualizado la sección 110.24 del Manual de Determinaciones de Cobertura Nacional de Medicare para incluir la cobertura de la terapia con linfocitos T con receptores quiméricos de antígenos (CAR) cuando se cumplan requisitos específicos.
¿Qué está cubierto?
Para las fechas de servicio a partir del 7 de agosto de 2019, los CMS cubren el tratamiento autólogo para el cáncer con linfocitos T que expresen al menos un receptor quimérico de antígenos (CAR) cuando se administre en centros médicos inscritos en las Estrategias de Evaluación y Mitigación de Riesgos (Risk Evaluation and Mitigation Strategies, REMS) de la Administración de Alimentos y Medicamentos (FDA) y cuando se cumplan requisitos específicos.
¿Quiénes están cubiertos?
Los beneficiarios que reciban tratamiento autólogo para el cáncer con linfocitos T que expresen al menos un receptor quimérico de antígenos (CAR), cuando se cumplan todos los requisitos siguientes:
El tratamiento autólogo es para el cáncer, con linfocitos T que expresen al menos un receptor quimérico de antígenos (CAR).
El tratamiento se administra en un centro médico inscrito en las REMS de la FDA.
La terapia se usa para una indicación médicamente aceptada, que se define como el uso para una indicación aprobada por la FDA según la etiqueta de ese producto o el uso que tiene apoyo de uno o más compendios aprobados por los CMS.
Uso no cubierto:
No se cubre el uso de linfocitos T autólogos sin aprobación de la FDA que expresen al menos un CAR, o cuando no se cumplan los requisitos de cobertura.
Haga clic aquí para obtener más información sobre la cobertura de la terapia con linfocitos T con receptores quiméricos de antígenos (CAR).
15. Examen de diagnóstico de cáncer colorrectal (CRC): pruebas de biomarcadores basados en la sangre
(Entrada en vigor: 19 de enero de 2021)
(Fecha de implementación: 4 de octubre de 2021)
¿Qué está cubierto?
A partir del 19 de enero de 2021, los CMS han determinado que las pruebas de biomarcadores basados en la sangre son un examen apropiado de diagnóstico de cáncer colorrectal una vez cada 3 años para beneficiarios de Medicare cuando se cumplen determinados requisitos.
¿Quiénes están cubiertos?
Los beneficiarios de Medicare tendrán cubierto un examen de diagnóstico de cáncer colorrectal basado en la sangre una vez cada 3 años cuando lo ordene un médico tratante y se cumplan las siguientes condiciones:
el procedimiento se haga en un laboratorio con certificación según la Ley de Mejoramiento de Laboratorios Clínicos (Clinical Laboratory Improvement Act, CLIA);
El paciente:
tenga entre 50 y 85 años;
sea asintomático (sin señales ni síntomas de enfermedad colorrectal, incluyendo, por ejemplo, dolor gastrointestinal en la parte baja del abdomen, sangre en las heces, resultado positivo en la prueba de sangre oculta en heces o la prueba inmunoquímica fecal); y
tenga un riesgo promedio de tener cáncer colorrectal (sin historia personal de pólipos adenomatosos, cáncer colorrectal ni enfermedad inflamatoria intestinal, incluyendo enfermedad de Crohn y colitis ulcerosa; sin historia familiar de cáncer colorrectal ni pólipos adenomatosos, poliposis adenomatosa familiar ni cáncer colorrectal hereditario no poliposo).
El examen de diagnóstico debe tener todo lo siguiente:
autorización de comercialización de la Administración de Alimentos y Medicamentos (FDA) con una indicación para diagnóstico de cáncer colorrectal; y
características de desempeño comprobadas para un examen de diagnóstico con una sensibilidad superior o igual al 74 %, y una especificidad superior o igual al 90 % en la detección de cáncer colorrectal comparado con el estándar reconocido (en este momento, la colonoscopia es el aceptado), según los estudios esenciales incluidos en el etiquetado de la FDA.
¿Qué no está cubierto?
Todas las demás indicaciones para el diagnóstico de cáncer colorrectal que no se especifiquen en las reglamentaciones o en la Determinación de Cobertura Nacional arriba, incluyendo:
Todos los exámenes de diagnóstico de ADN en heces, con vigor entre el 28 de abril de 2008 hasta el 8 de octubre de 2014. Para las fechas de servicio a partir del 9 de octubre de 2014, todos los demás exámenes de diagnóstico de ADN en heces no especificados arriba siguen sin cobertura a nivel nacional.
Colonografía de diagnóstico por tomografía computarizada (CTC) de diagnóstico, en vigor a partir del 12 de mayo de 2009.
Haga clic aquí para obtener más información sobre la cobertura de la NGS.
16. Dispositivos de asistencia ventricular (VAD)
(Entrada en vigor: 1 de diciembre de 2020)
(Fecha de implementación: 27 de julio de 2021)
¿Qué está cubierto?
Para las fechas de servicio a partir del 1 de diciembre de 2020, los CMS han actualizado la sección 20.9.1 del Manual de Determinaciones de Cobertura Nacional para cubrir los dispositivos de asistencia ventricular (ventricular assist devices, VAD) cuando se reciben en centros con credenciales de una organización aprobada por los CMS y cuando se cumplan requisitos específicos.
¿Quiénes están cubiertos?
Beneficiarios que reciban tratamiento para la implantación de un dispositivo de asistencia ventricular (VAD), cuando se cumplan los siguientes requisitos:
El dispositivo se use después de una cardiotomía (período después de una cirugía de corazón abierto) para apoyar la circulación sanguínea.
El dispositivo debe estar aprobado por la Administración de Alimentos y Medicamentos (FDA) para este fin.
Reciban un dispositivo de asistencia ventricular izquierdo (LVAD) si esta aprobado por la FDA para uso de corto o largo plazo para apoyo circulatorio mecánico para beneficiarios con insuficiencia cardíaca que cumplan los siguientes requisitos:
tengan insuficiencia cardíaca de Clase IV de la New York Heart Association (NYHA);
tengan una fracción de eyección del ventrículo izquierdo (LVEF) ≤ 25 %; y
sean dependientes de inotrópicos O tengan un índice cardíaco (CI) < 2.2 L/min/m2, mientras no estén consumiendo inotrópicos, y cumplan uno de los siguientes:
estén bajo un control médico óptimo, basado en las directrices de prácticas para insuficiencia cardíaca actuales durante al menos 45 de los últimos 60 días y no estén respondiendo; o
tengan insuficiencia cardíaca avanzada durante al menos 14 días y dependan de una bomba de globo intraaórtico (IABP) o apoyo circulatorio mecánico temporal similar durante al menos 7 días.
Los beneficiarios deben estar bajo control de un equipo de profesionales médicos que cumplan los requisitos mínimos en el Manual de Determinaciones de Cobertura Nacional.
Los establecimientos deben tener credenciales de una organización aprobada por los CMS.
Uso no cubierto:
Todas las demás indicaciones para el uso de los VAD que no se mencionen siguen sin cobertura, excepto en el contexto de los ensayos clínicos con exención de dispositivos en investigación de categoría B (Título 42 del CFR 405) o como costo de rutina en ensayos clínicos definidos en la sección 310.1 del Manual de Determinaciones de Cobertura Nacional (NCD).
Haga clic aquí para obtener más información sobre la cobertura de dispositivos de asistencia ventricular (VAD).
17. Productos derivados de la sangre para heridas crónicas que no cicatrizan
(Entrada en vigor: 13 de abril de 2021)
(Fecha de implementación: 14 de febrero de 2022)
¿Qué está cubierto?
Para las fechas de servicio a partir del 13 de abril de 2021, los CMS han actualizado la sección 270.3 del Manual de Determinaciones de Cobertura Nacional para cubrir el plasma rico en plaquetas (Platelet-Rich Plasma, PRP) autólogo (obtenido de la misma persona) cuando se cumplan requisitos específicos.
¿Quiénes están cubiertos?
Los beneficiarios que reciban tratamiento durante 20 semanas para heridas diabéticas crónicas que no cicatricen, cuando se prepare con un dispositivo autorizado por la Administración de Alimentos y Medicamentos (FDA) para el tratamiento de heridas exudantes (sangrantes, purulentas, supurantes, etc.) que afecten a la piel.
Uso no cubierto:
Se considera que los siguientes usos no están cubiertos:
uso de factor de crecimiento derivado de plaquetas (PDGF) autólogo para el tratamiento de heridas cutáneas (que afecten a la piel) crónicas que no cicatricen;
becaplermin, un factor de crecimiento no autólogo para heridas subcutáneas (debajo de la piel) crónicas que no cicatricen;
tratamiento con plasma rico en plaquetas (PRP) autólogo para heridas quirúrgicas agudas cuando se aplique directamente sobre la incisión cerrada o para heridas abiertas.
Otros:
Los contratistas administrativos locales de Medicare determinarán la cobertura para el tratamiento después de las 20 semanas, o para todas las demás heridas crónicas que no cicatricen.
Haga clic aquí para obtener más información sobre la cobertura de productos derivados de la sangre para heridas crónicas que no cicatrizan.
18. Reparación transcatéter borde a borde (TEER) por regurgitación de la válvula mitral
(Entrada en vigor: 19 de enero de 2021)
(Fecha de implementación: 8 de octubre de 2021)
¿Qué está cubierto?
Para las fechas de servicio a partir del 19 de enero de 2021, los CMS han actualizado la sección 20.33 del Manual de Determinaciones de Cobertura Nacional para cubrir la reparación transcatéter borde a borde (Transcatheter Edge-to-Edge Repair, TEER) por regurgitación de la válvula mitral cuando se cumplan requisitos específicos.
¿Quiénes están cubiertos?
Los beneficiarios que reciban tratamiento para la reparación transcatéter borde a borde (TEER) cuando se cumpla cualquiera de las siguientes condiciones:
Para el tratamiento de regurgitación de la válvula mitral (MR) sintomática de moderada a grave cuando el paciente todavía tenga síntomas, a pesar de recibir dosis estables de terapia médica dirigida según las directrices (GDMT) al máximo tolerado y terapia de resincronización cardíaca, cuando corresponda y se cumpla lo siguiente:
el tratamiento sea una indicación con aprobación de la Administración de Alimentos y Medicamentos (FDA);
el procedimiento se use con un sistema de TEER de válvula mitral que haya aprobación de la solicitud la comercialización por parte de la FDA.
El beneficiario está bajo el cuidado preoperatorio o posoperatorio de un equipo cardíaco que cumpla lo siguiente:
El cirujano cardíaco cumple los requisitos mencionados en la determinación.
El cardiólogo intervencionista cumple los requisitos mencionados en la determinación.
El ecocardiógrafo intervencionista cumple los requisitos mencionados en la determinación.
El cardiólogo tratante de la insuficiencia cardíaca tiene experiencia tratando pacientes con insuficiencia cardíaca avanzada.
Los proveedores de otros grupos incluyen proveedores de asistencia médica, enfermeros, personal de investigación y administradores.
Se debe evaluar al paciente para determinar si es apto para la reparación, y se debe documentar y poner la documentación a disposición de los miembros del equipo de tratamiento cardíaco que cumplan los requisitos de esta determinación.
Un cardiólogo intervencionista o cirujano cardíaco debe hacer el procedimiento.
Un ecocardiógrafo intervencionista debe hacer la ecocardiografía transesofágica durante el procedimiento.
Todos los médicos que participen en el procedimiento deben haber recibido una capacitación específica sobre el dispositivo de parte del fabricante del dispositivo.
El procedimiento debe hacerse en un hospital con infraestructura y experiencia que cumpla los requisitos incluidos en esta determinación.
El equipo cardíaco debe participar en el registro nacional y hacer un seguimiento de los resultados según los requisitos incluidos en esta determinación.
Las TEER de válvula mitral se cubren para otros usos que no son indicaciones aprobadas por la FDA cuando se hacen en un estudio clínico y se cumplen los siguientes requisitos:
Un cardiólogo intervencionista o cirujano cardíaco debe hacer el procedimiento.
Un ecocardiógrafo intervencionista debe hacer la ecocardiografía transesofágica durante el procedimiento.
Todos los médicos que participen en el procedimiento deben haber recibido una capacitación específica sobre el dispositivo de parte del fabricante del dispositivo.
La investigación clínica debe evaluar las doce preguntas obligatorias según esta determinación.
La investigación clínica debe evaluar la calidad de vida del paciente antes y después durante un período mínimo de un año y responder al menos una de las preguntas de esta sección de la determinación.
El estudio de investigación clínica debe cumplir los estándares de integridad científica y relevancia para la población de Medicare que se describen en esta determinación.
Se debe presentar la información del estudio solicitada a los CMS para su aprobación.
Uso no cubierto:
Se considera que los siguientes usos no están cubiertos:
Tratamiento para pacientes con comorbilidades existentes que impedirían el beneficio del procedimiento.
Tratamiento para pacientes con estenosis aórtica grave sin tratar.
Otros:
Esta determinación vencerá diez años después de la fecha de entrada en vigor si no se reconsidera durante este período. Una vez vencida, los contratistas administrativos locales de Medicare (MAC) determinarán la cobertura.
Haga clic aquí para obtener más información sobre la cobertura de la reparación transcatéter borde a borde (TEER) por regurgitación de la válvula mitral.
19. Tomografía por emisión de positrones NaF-18 (NaF-18 PET) para identificar metástasis óseas del cáncer - Solo actualización del manual
(Entrada en vigor: 15 de diciembre de 2017)
(Fecha de implementación: 17 de enero de 2022)
Para las fechas de servicio a partir del 15 de diciembre de 2017, los CMS han actualizado la sección 220.6.19 del Manual de Determinaciones de Cobertura Nacional aclarando que no hay indicaciones cubiertas a nivel nacional para la tomografía por emisión de positrones NaF-18 (NaF-18 PET).
Uso no cubierto:
Los servicios de tomografía por emisión de positrones NaF-18 (NaF-18 PET) para identificar metástasis óseas del cáncer que se presten el 15 de diciembre de 2017 o después no están cubiertos a nivel nacional.
Otros
Es posible que esté cubierto el uso de otros trazadores radiofarmacéuticos para PET, a discreción de los contratistas administrativos locales de Medicare (MAC), cuando se usen según las indicaciones con aprobación de la Administración de Alimentos y Medicamentos (FDA).
Haga clic aquí para obtener más información sobre la cobertura de la tomografía por emisión de positrones NaF-18 (NaF-18 PET) para identificar metástasis óseas del cáncer.
La información en esta página está vigente desde el 28 de diciembre de 2021
H5355_CMC_22_2746205 Accepted
20. Uso de oxígeno en el domicilio
(Entrada en vigor: 27 de septiembre de 2021)
(Fecha de implementación: 3 de enero de 2023)
¿Qué está cubierto?
A partir del 27 de septiembre de 2021, los CMS han actualizado la sección 240.2 del Manual de Determinaciones de Cobertura Nacional para cubrir la oxigenoterapia y el equipo de oxígeno para uso en el domicilio para condiciones agudas y crónicas, de corto o largo plazo, cuando un paciente tenga hipoxemia. Los CMS han actualizado la sección 240.2 del Manual de Determinaciones de Cobertura Nacional para modificar el período de cobertura inicial para pacientes en la sección D de NCD 240.2 de 120 días a 90 días, para que se alinee con el período obligatorio de 90 días.
¿Quiénes están cubiertos?
Los beneficiarios que tengan hipoxemia (bajo nivel de oxígeno en sangre) cuando se cumplan TODAS (A, B y C) las siguientes:
A. La hipoxemia se basa en los resultados de un examen clínico ordenado y evaluado por el proveedor de asistencia médica tratante del paciente, que cumpla con alguna de las siguientes:
a. Un examen clínico que dé una medición de la presión parcial de oxígeno (PO2) en la sangre arterial.
i. Las mediciones de PO2 pueden obtenerse mediante el oído o mediante pulsioxímetro.
ii. El proveedor de asistencia médica tratante, un proveedor calificado o un proveedor de servicios de laboratorio puede obtener la PO2.
b. Un examen clínico que mida los gases en la sangre arterial.
i. Si los resultados de PO2 y gases en la sangre arterial son contradictorios, se prefieren los resultados de gases en la sangre arterial como fuente para determinar la necesidad médica.
B. El examen clínico debe hacerse en el momento de la necesidad:
a. La presunción de que la oxigenoterapia en el domicilio mejorará la condición del paciente señala el momento de necesidad.
i. Para pacientes hospitalizados, el momento de necesidad es en un plazo de 2 días después del alta.
ii. En el caso de pacientes a los que no se les prescribió oxígeno inicialmente durante la estancia en el hospital, el momento de necesidad tiene lugar cuando el proveedor de asistencia médica tratante identifique señales y síntomas de hipoxemia que puedan aliviarse con oxigenoterapia en el domicilio.
C. El diagnóstico del beneficiario se ajusta a uno de los siguientes grupos definidos abajo:
a. Grupo I:
i. PO2 arterial de 55 mmHg o inferior, o saturación de oxígeno arterial de 88 % o inferior, cuando se hace la prueba en reposo con aire ambiental;
ii. PO2 arterial de 55 mmHg o inferior, o saturación de oxígeno arterial de 88 % o inferior, cuando se hace la prueba al dormir para pacientes con PO2 arterial de 56 mmHg o superior; o
iii. Saturación de oxígeno arterial del 89 % o superior cuando está despierto; o mayor disminución del nivel de oxígeno que lo normal mientras duerme, representada por una disminución de PO2 arterial de más de 10 mmHg o una disminución de la saturación de oxígeno arterial de más del 5 %.
a. El paciente también debe tener señales y síntomas de hipoxemia, como agitación nocturna, insomnio o deterioro del proceso cognitivo.
2. Durante estos eventos, el oxígeno durante el sueño es el único tipo de unidad que se cubrirá.
3. No se cubriría el oxígeno para la deambulación.
iv. PO2 arterial de 55 mmHg o inferior o saturación de oxígeno arterial del 88 % o inferior cuando se hace la prueba durante el desempeño funcional del paciente o un ejercicio formal.
1. Para un paciente que tiene PO2 arterial de 56 mmHg o superior, o una saturación de oxígeno arterial de 89 % o superior, en reposo y durante el día.
2. Durante estos eventos, el oxígeno suplementario se administra durante el ejercicio, si el uso de oxígeno mejora la hipoxemia que se comprobó durante el ejercicio cuando el paciente respiraba aire ambiental.
b. Grupo II:
i. Pacientes que tienen PO2 arterial de 56-59 mmHg, o con saturación de oxígeno en sangre arterial del 89 %, con cualquiera de las siguientes afecciones:
1. Edema dependiente (hinchazón relacionada con la gravedad debido al exceso de líquidos) que sugiere insuficiencia cardíaca congestiva.
2. Hipertensión pulmonar o cor pulmonale (presión arterial alta en las arterias pulmonares), determinada mediante la medición de la presión arterial pulmonar, escintigrafía sanguínea compartimentada, ecocardiograma o “P” pulmonar en EKG (onda P mayor que 3 mm en las derivaciones estándar II, III, o AVFL).
3. Eritrocitosis (aumento de glóbulos rojos) con hematocrito superior al 56 %.
c. Los contratistas administrativos de Medicare (MAC) revisarán los niveles de PO2 arterial de arriba y también tendrán en cuenta diversas mediciones de oxígeno que puedan ser resultado de factores como la edad del paciente, la pigmentación de la piel del paciente, el nivel de altitud y la capacidad de transporte de oxígeno reducida del paciente.
Uso no cubierto:
No se cubren las siguientes afecciones médicas para oxigenoterapia ni equipo de oxígeno en el domicilio:
angina de pecho (dolor en el pecho) sin hipoxemia;
falta de aire sin cor pulmonale ni evidencia de hipoxemia;
enfermedad vascular periférica grave que ocasione desaturación clínicamente evidente en una o más extremidades; o
enfermedades terminales, a menos que afecten la capacidad de respirar del paciente.
Otros:
El MAC podrá determinar la cobertura necesaria para la oxigenoterapia en el domicilio para pacientes que no cumplan los criterios que se describieron arriba. La cobertura inicial para pacientes que tengan afecciones que no se describen arriba puede limitarse a una receta de menos de 90 días, o una cantidad de días menor que la indicada en la receta del proveedor de asistencia médica. El MAC puede renovar la oxigenoterapia si se considera médicamente necesario.
El MAC también puede aprobar el uso de sistemas de oxígeno de deambulación para beneficiarios que deambulen en su casa y se benefician de esta unidad sola o en conjunto con un sistema de oxígeno fijo.
Para obtener más información sobre la cobertura del uso de oxígeno en el domicilio haga clic aquí.
21. 180.1 - Terapia médica de nutrición (MNT)
(Entrada en vigor: 1 de enero de 2022)
(Fecha de implementación: 5 de julio de 2022)
¿Qué está cubierto?
Para las fechas de servicio a partir del 1 de enero de 2022, los CMS han actualizado la sección 180.1 del Manual de Determinaciones de Cobertura Nacional para cubrir tres horas de administración durante un año de terapia médica de nutrición (Medical Nutrition Therapy, MNT) en pacientes con un diagnóstico de enfermedad renal o diabetes, según se define en el Título 42 del CFR, artículo 410.130. La cobertura para años futuros es de dos horas para pacientes con un diagnóstico de enfermedad renal o diabetes.
Medicare cubrirá la MNT y capacitación sobre control personal de la diabetes para pacientes ambulatorios (DSMT) durante el año inicial y los siguientes, si el médico determina que el tratamiento es médicamente necesario, y siempre y cuando no se administre DSMT y MNT en la misma fecha.
Los dietistas y nutricionistas determinarán cuántas unidades se administrarán al día, y se deben cumplir los requisitos de esta NCD y del Título 42 del CFR, artículos 410.130 – 410.134. Las horas adicionales de tratamiento se consideran médicamente necesarias si un médico determina que ha habido un cambio en la afección, diagnóstico o régimen de tratamiento del paciente que requiera un ajuste en la orden de MNT u horas adicionales de atención.
¿Quiénes están cubiertos?
Los beneficiarios con diagnóstico de enfermedad renal o diabetes, según se define en el Título 42 del CFR, artículo 410.130.
Para obtener más información sobre la cobertura de la terapia médica de nutrición (MNT), haga clic aquí.
22. Reconsideración – Examen de diagnóstico de cáncer pulmonar con tomografía computarizada de baja dosis (LDCT)
(Entrada en vigor: 10 de febrero de 2022)
(Fecha de implementación: 3 de octubre de 2022)
¿Qué está cubierto?
Para los reclamos con fechas de servicio a partir del 10 de febrero de 2022, los CMS cubrirán, mediante Medicare Parte B, una visita de orientación para el examen de diagnóstico de cáncer pulmonar y toma de decisiones compartida. Habrá disponible un examen de diagnóstico anual de cáncer pulmonar con LDCT si se cumplen criterios de elegibilidad específicos.
Antes del primer examen de diagnóstico para cáncer pulmonar con LDCT del beneficiario, el beneficiario debe hacer una visita de orientación y toma de decisiones compartida que cumpla los criterios específicos.
¿Quiénes están cubiertos?
Los miembros deben cumplir todos los criterios de elegibilidad siguientes:
tener entre 50 y 77 años de edad;
ser asintomáticos (sin señales ni síntomas de cáncer pulmonar);
haber fumado tabaco durante al menos 20 paquete-años (un paquete-año = fumar un paquete al día durante un año; 1 paquete = 20 cigarrillos);
ser fumadores actualmente o haber dejado de fumar en el plazo de los últimos 15 años;
recibir una orden para un examen de diagnóstico de cáncer pulmonar con LDCT.
Haga clic aquí para obtener más información sobre la cobertura de la LDCT.
23. (Anticuerpos monoclonales dirigidos contra el amiloide para el tratamiento de la enfermedad de Alzheimer [AD])
(Fecha de vigencia: 7 de abril de 2022)
(Fecha de implementación: 12 de diciembre de 2022)
Qué está cubierto:
A partir del 7 de abril de 2022, los Centros de Servicios de Medicare y Medicaid (Centers for Medicare and Medicaid Services, CMS) actualizaron la sección 200.3 del Manual de determinación de cobertura nacional (National Coverage Determination, NCD) para cubrir los anticuerpos monoclonales aprobados por la Administración de Alimentos y Medicamentos (Food and Drug Administration, FDA) dirigidos contra el amiloide para el tratamiento de la enfermedad de Alzheimer (Alzheimer’s Disease, AD) cuando el criterio de cobertura a continuación se cumple.
Quiénes están cubiertos:
Es posible que los beneficiarios con enfermedad de Alzheimer (AD) estén cubiertos para recibir tratamiento cuando se cumplen las siguientes condiciones (A o B):
El tratamiento se basa en la eficacia de un cambio en el criterio de valoración alternativo, como la reducción de amiloide. Se considera que el tratamiento tiene una probabilidad razonable de predecir un beneficio clínico y se administra en un ensayo controlado aleatorio bajo la solicitud de un nuevo medicamento en investigación.
El tratamiento se basa en la eficacia de una medida directa de beneficio clínico en estudios comparativos prospectivos aprobados por los CMS. Los datos de estudio para estudios comparativos prospectivos aprobados por los CMS pueden recolectarse en un registro.
Para los estudios aprobados por los CMS, el protocolo, incluido el plan de análisis, debe cumplir con requisitos mencionados en esta NCD.
Los estudios aprobados por los CMS de un anticuerpo monoclonal dirigido contra el amiloide aprobado por la FDA para el tratamiento de la AD con base en la evidencia de eficacia de una medida directa de beneficio clínico deben abordar todas las preguntas incluidas en la sección B.4 de esta Determinación de cobertura nacional.
Los estudios aprobados por los CMS deben apegarse a los estándares de integridad científica que fueron identificados en la sección 5 de esta NCD por la Agencia para la Investigación y Calidad de la Atención Médica (Agency for Healthcare Research and Quality, AHRQ).
Para obtener más información sobre el diseño del estudio y los requisitos de justificación aquí.
Uso sin cobertura:
Anticuerpos monoclonales dirigidos contra el amiloide para el tratamiento de la AD proporcionados fuera de un ensayo controlado aleatorio aprobado por la FDA, estudios aprobados por los CMS o estudios respaldados por los Institutos Nacionales de Salud (National Institutes of Health, NIH).
Otro:
N/A
Para obtener más información sobre los Anticuerpos monoclonales dirigidos contra el amiloide para el tratamiento de la enfermedad de Alzheimer (AD) aquí.
24. Exámenes de diagnóstico de cáncer colorrectal
(Fecha de vigencia: 1 de enero de 2023)
(Fecha de implementación: 27 de febrero de 2023)
Qué está cubierto:
A partir del 1.º de enero de 2023, los Centros de Servicios de Medicare y Medicaid (Centers for Medicare and Medicaid Services, CMS) actualizaron la sección 210.3 del Manual de Determinaciones de Cobertura Nacional (National Coverage Determinations, NCD) que proporciona cobertura para exámenes de diagnóstico de cáncer colorrectal (Colorectal Cancer, CRC) de acuerdo con Medicare Parte B.
Quiénes están cubiertos:
Los beneficiarios que tengan al menos 45 años de edad o más pueden realizarse los siguientes exámenes cuando se cumplan todos los criterios de Medicare que se mencionan en esta determinación de cobertura nacional:
Prueba de sangre oculta en la materia fecal (Fecal Occult Blood Tests, gFOBT), una vez cada 12 meses
Cologuard™: prueba de ADN en heces (Stool DNA, sDNA) de varios objetivos, una vez cada tres años
Prueba de biomarcador basado en la sangre, una vez cada tres años
Uso sin cobertura:
Todas las demás indicaciones para las evaluaciones de detección de cáncer colorrectal que, de otra manera, no se especifiquen en la Ley de Seguridad Social, las regulaciones o lo anterior permanecen no cubiertas a nivel nacional. La no cobertura incluye específicamente lo siguiente:
Todos los exámenes de diagnóstico de sDNA, a partir del 28 de abril de 2008, hasta el 8 de octubre de 2014. Vigente para las fechas de servicios del 9 de octubre de 2014 o una fecha posterior, todos los demás exámenes de diagnóstico de sDNA que se especifican anteriormente permanecen no cubiertos a nivel nacional.
Evaluación de colonografía por tomografía computarizada (Computed Tomographic Colonography, CTC), vigente a partir del 12 de mayo de 2009.
Haga clic aquí para más información sobre el monitoreo electroencefalográfico ambulatorio y los exámenes de diagnóstico de cáncer colorrectal.
La información en la página está actualizada al 14 de febrero de 2023
H8894_DSNP_23_3820564_M Accepted
MediCal - Forms
liance
Delegation Oversight Audit (DOA)
Grievance
Growth Chart
Health and Wellness
Historical Data Form
Inland Regional Center
Medi-Cal Letter Templates
Medicare-Medicaid Plan Letter Templates
D-SNP Letter Templates
Medicare
Non-Contracted Providers
Perinatal
Pharmacy
Provider Preventable Conditions (PPC)
UM/CM
Vision
Other
Behavioral Health
ABA 6 Month and Exit Progress Report Template (Word)
ABA Exit Letter Template (Word)
ABA Service Hour Log (Word)
ABA School BHT Services Request Form (Word)
Authorization Release of Information Form - English (PDF)
Authorization Release of Information Form - Spanish (PDF)
Behavioral Health Authorization Request Form (PDF)
BHT Social Skills Template (Word)
Coordination of Care Treatment Plan Form (PDF)
No Further Treatment Request Form (PDF)
Psych Testing Battery Plan (for Psychologist use only) (PDF)
Claims
For Integrated Denial Notices please click here.
Please select on the links below to obtain the revised CMS 1500 form (version 02/12) and the CMS 1500 Reference Instruction Manual.
Provider Identified Overpayment Form (PDF)
Provider Identified Overpayment Form (Multiple) (PDF)
Provider Dispute Resolution (PDR) (PDF)
Claims Project Spreadsheet (Excel)
Clean Claim Tool Guide - UB04 Inpatient Form (PDF)
Clean Claim Tool Guide - UB04 Outpatient Form (PDF)
Waiver of Liability Statement - IEHP Dual Choice (HMO D-SNP) - effective January 2023 (PDF)
Revised CMS 1500 Health Insurance Claim Form (PDF)
CMS 1500 Reference Instruction Manual (PDF)
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Compliance
Member Incentive Forms
Focus Group Incentive (FGI) - Request for Approval Form (PDF)
Focus Group Incentive (FGI) - Evaluation Form (PDF)
Member Incentive (MI) Program - Request for Approval (PDF)
Member Incentive (MI) Program - Annual Update/End of Program Evaluation (PDF)
Survey Incentive (SI) - Request for Approval Form (PDF)
Survey Incentive (SI) - Evaluation Form (PDF)
Nondiscrimination Language
Nondiscrimination Language Access Notice:
Medi-Cal (PDF)
Medicare (PDF)
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Delegation Oversight Audit (DOA)
Biographical Information Sheet
Credentialing DOA Audit Tool
HIPAA Security - Medi-Cal DOA
HIPAA Security - Medicare
Medi-Cal DOA Tool UM/CM/QI
Medicare DOA Tool UM/CM/QI
Medi-Cal UM Referral Template
Sub-Contracted Facility/Agency Services and Delegated Functions
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Grievance
The Grievance Forms below are for your Member's use when filing a complaint, or has an appeal regarding any aspect of care or service provided by you. Please select the Appeal and Grievance form appropriate for their use:
Medi-Cal Form
English (PDF)
Spanish (PDF)
Chinese (PDF)
Vietnamese (PDF)
Medicare Form
English (PDF)
Spanish (PDF)
Chinese (PDF)
Vietnamese (PDF)
The following IEHP DualChoice (HMO D-SNP) Letters will be effective January 1, 2023:
English (PDF)
Spanish (PDF)
Chinese (PDF)
Vietnamese (PDF)
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Growth Chart
Inland Empire Health Plan (IEHP) offers you easy access to useful reference materials and forms you may need. It's just one click away. Select the growth chart form that you need by clicking on the link below:
(0-36 months): Head Circumference-For-Age And Weight- For-Length Percentiles
Boys (PDF) Girls (PDF)
(0-36 months): Length and Weight-For-Age Percentiles
Boys (PDF) Girls (PDF)
(2-20 years): Stature and Weight-For-Age-Percentiles
Boys (PDF) Girls (PDF)
(2-20 years): Body Mass Index For-Age Percentiles
Boys (PDF) Girls (PDF)
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Health and Wellness
DPP Rx Pad (PDF)
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Historical Data Form
Historical Data Form (PDF)
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Inland Regional Center
Early Start (0-36 months) Referral (PDF)
Early Start Online Application
Eligibility and Intake
IRC Referrals (3-99+ years):
San Bernardino County: For Providers - (909) 890-4711 // Intake - (909) 890-3148
Riverside County: For Providers - (909) 890-4763 // Intake - (951) 826-2648
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Medi-Cal Letter Templates
A complete template includes all documents listed under each template in the order specified listed. Changes can only be made to highlighted areas, any changes made outside of the highlighted areas are strictly prohibited by DHCS.
Click on the title to expand the menu and download desired document.
Member Authorization Letter
English
Last Updated: 09/20/2022
Spanish
Last Updated: 09/20/2022
Chinese
Last Updated: 09/20/2022
Vietnamese
Last Updated: 09/20/2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated August 01, 2022
Continuity of Care Authorization Letter
English
Last Updated: 09/20/2022
Spanish
Last Updated: 09/20/2022
Chinese
Last Updated: 09/20/2022
Vietnamese
Last Updated: 09/20/2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated August 01, 2022
Notice of Action – Carve Out
English
Last Updated: 12/29/2022
Spanish
Last Updated: 12/29/2022
Chinese
Last Updated: 12/29/2022
Vietnamese
Last Updated: 12/29/2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated August 01, 2022
Notice of Action - Delay
English
Last Updated: 12/27/2022
Spanish
Last Updated: 12/27/2022
Chinese
Last Updated: 12/27/2022
Vietnamese
Last Updated: 12/27/2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated August 01, 2022
Notice of Action - Deny
English
Last Updated: 12/27/2022
Spanish
Last Updated: 12/27/2022
Chinese
Last Updated: 12/27/2022
Vietnamese
Last Updated: 12/27/2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated August 01, 2022
Notice of Action - Modify
English
Last Updated: 12/28/2022
Spanish
Last Updated: 12/28/2022
Chinese
Last Updated: 12/28/2022
Vietnamese
Last Updated: 12/28/2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated August 01, 2022
Notice of Action - Terminate
English
Last Updated: 01/06/2023
Spanish
Last Updated: 01/06/2023
Chinese
Last Updated: 01/06/2023
Vietnamese
Last Updated: 01/06/2023
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated August 01, 2022
Other Health Care Coverage Requesting Provider Letter
English
Last Updated: 03/17/2021
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated August 01, 2022
Continuity of Care Terminate Letter
English
Last Updated: 09/20/2022
Spanish
Last Updated: 09/20/2022
Chinese
Last Updated: 09/20/2022
Vietnamese
Last Updated: 09/20/2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated August 01, 2022
Specialist Termination Letter
English
Last Updated: 09/20/2022
Spanish
Last Updated:09/20/2022
Chinese
Last Updated:09/20/2022
Vietnamese
Last Updated:09/20/2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated August 01, 2022
Prior Authorization Not Required
English
Last Updated: 09/20/2022
Spanish
Last Updated:09/20/2022
Chinese
Last Updated:09/20/2022
Vietnamese
Last Updated:09/20/2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated August 01, 2022
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Medicare-Medicaid Plan Letter Templates
A complete template includes all documents listed under each template in the order specified listed. Changes can only be made to highlighted areas, any changes made outside of the highlighted areas are strictly prohibited by CMS.
Click on the title to expand the menu and download desired document.
Carve-Out Information Letter
English
Last Updated: 11/12/2017
Spanish
Last Updated: 10/31/2017
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Denial Reason Matrix
English
Last Updated: 07/03/2018
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Detailed Explanation of Non-Coverage
English
Last Updated: 12/17/2021
Spanish
Last Updated: 12/17/2021
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Detailed Notice of Discharge
English
Last Updated: 12/17/2021
Spanish
Last Updated: 12/17/2021
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Expedited Criteria Not Met
English
Last Updated: 10/31/2017
Spanish
Last Updated: 10/31/2017
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Extension Needed for Additional Information
English
Last Updated: 10/31/2017
Spanish
Last Updated: 10/31/2017
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Integrated Denial Notice - Part B Drugs - 7 day appeal - IPA
English
Last Updated: 02/14/2022
Spanish
Last Updated: 02/14/2022
Chinese
Last Updated: 02/14/2022
Vietnamese
Last Updated: 02/14/2022
Independent Medical Review - [English] [Spanish] [Chinese] [Vietnamese] Updated October 7, 2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Integrated Denial Notice - Part C - 30 day appeal - IPA
English
Last Updated: 03/08/2022
Spanish
Last Updated: 02/14/2022
Chinese
Last Updated: 02/14/2022
Vietnamese
Last Updated: 02/14/2022
Independent Medical Review - [English] [Spanish] [Chinese] [Vietnamese] Updated October 7, 2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Integrated Denial of Payment Notice - 7 day appeal - IPA
English
Last Updated: 03/17/2021
Spanish
Last Updated: 10/18/2021
Independent Medical Review - [English] [Spanish] [Chinese] [Vietnamese] Updated October 7, 2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Integrated Denial of Payment Notice - 30 day appeal - IPA
English
Last Updated: 03/17/2021
Spanish
Last Updated: 04/12/2017
Independent Medical Review - [English] [Spanish] [Chinese] [Vietnamese] Updated October 7, 2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Notice of Authorization of Services
English
Last Updated: 10/31/2017
Spanish
Last Updated: 10/31/17
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Notice of Dismissal of Coverage
English
Last Updated:03/10/2022
Spanish
Last Updated:03/10/2022
Chinese
Last Updated:03/10/2022
Vietnamese
Last Updated:03/10/2022
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Notice of Medicare Non-Coverage
English
Last Updated: 10/31/2017
Spanish
Last Updated: 10/31/2017
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
Notice of Reinstatement of Coverage
English
Last Updated: 10/31/2017
Spanish
Last Updated: 10/31/2017
Nondiscrimination Notice & Taglines - [English] [Spanish] [Chinese] [Vietnamese] Updated October 27, 2022
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NEW D-SNP Letter Templates
These templates should not be used until the effective date of January 2, 2023. Please continue using the current Medicare DualChoice letter templates currently seen on this webpage for the remainder of 2022.
A complete template includes all documents listed under each template in the order specified listed. Changes can only be made to highlighted areas, any changes made outside of the highlighted areas are strictly prohibited by CMS.
Click on the title to expand the menu and download desired document.
AOR Dismissal Letter
English
Last Updated: 09/26/2022
Spanish
Last Updated:09/26/2022
Chinese
Last Updated:09/26/2022
Vietnamese
Last Updated:09/26/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
AOR Request Letter
English
Last Updated: 09/26/2022
Spanish
Last Updated:09/26/2022
Chinese
Last Updated:09/26/2022
Vietnamese
Last Updated:09/26/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Continuity of Care - Notice of Authorization
English
Last Updated: 09/26/2022
Spanish
Last Updated:09/26/2022
Chinese
Last Updated:09/26/2022
Vietnamese
Last Updated:09/26/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Continuity of Care – Notice of Termination
English
Last Updated: 09/26/2022
Spanish
Last Updated:09/26/2022
Chinese
Last Updated:09/26/2022
Vietnamese
Last Updated:09/26/2022
Nondiscrimination Notice, Tagline, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Detailed Explanation of Non-Coverage
English
Last Updated: 09/26/2022
Spanish
Last Updated:09/26/2022
Chinese
Last Updated:09/26/2022
Vietnamese
Last Updated:09/26/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Detailed Notice of Discharge
English
Last Updated: 12/20/2022
Spanish
Last Updated:12/20/2022
Chinese
Last Updated:12/20/2022
Vietnamese
Last Updated:12/20/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Expedited Criteria Not Met
English
Last Updated: 09/26/2022
Spanish
Last Updated: 09/26/2022
Chinese
Last Updated: 09/26/2022
Vietnamese
Last Updated: 09/26/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Extension Needed for Additional Information
English
Last Updated: 09/26/2022
Spanish
Last Updated: 09/26/2022
Chinese
Last Updated: 09/26/2022
Vietnamese
Last Updated: 09/26/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Informational Letter to Beneficiary and PCP
English
Last Updated: 09/26/2022
Spanish
Last Updated: 09/26/2022
Chinese
Last Updated: 09/26/2022
Vietnamese
Last Updated: 09/26/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Notice of Authorization of Services
English
Last Updated: 09/27/2022
Spanish
Last Updated: 09/27/2022
Chinese
Last Updated: 09/27/2022
Vietnamese
Last Updated: 09/27/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Notice of Dismissal of Coverage Request
English
Last Updated: 09/26/2022
Spanish
Last Updated: 09/26/2022
Chinese
Last Updated: 09/26/2022
Vietnamese
Last Updated: 09/26/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Notice of Medicare Non-Coverage
English
Last Updated:09/27/2022
Spanish
Last Updated:09/27/2022
Chinese
Last Updated:09/27/2022
Vietnamese
Last Updated:09/27/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Cancelled Relocation Letter
English
Last Updated: 09/22/2022
Spanish
Last Updated:09/22/2022
Chinese
Last Updated:09/22/2022
Vietnamese
Last Updated:09/22/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Long-Term Care IPA and PCP Change Letter
English
Last Updated: 09/26/2022
Spanish
Last Updated:09/26/2022
Chinese
Last Updated:09/26/2022
Vietnamese
Last Updated:09/26/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Coverage Decision Letter Part B - 7 Day Appeal
English
Last Updated: 10/03/2022
Spanish
Last Updated:10/03/2022
Chinese
Last Updated:10/03/2022
Vietnamese
Last Updated:10/03/2022
*Additional Information for IPAs: Please include the integrated Coverage Decision Letter, the most recent IMR form, application instructions, DMHC’s toll-free telephone number, and an envelope addressed to DMHC.
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Independent Medical Review (IMR) Form - [English] [Spanish] [Chinese] [Vietnamese] Updated January 01, 2023
State Fair Hearing Form - [English] [Spanish] [Chinese] [Vietnamese] Updated September 01, 2021
Coverage Decision Letter Medical – 30 Day Appeal
English
Last Updated: 10/03/2022
Spanish
Last Updated:10/03/2022
Chinese
Last Updated:10/03/2022
Vietnamese
Last Updated:10/03/2022
*Additional Information for IPAs: Please include the integrated Coverage Decision Letter, the most recent IMR form, application instructions, DMHC’s toll-free telephone number, and an envelope addressed to DMHC.
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
Independent Medical Review (IMR) Form - [English] [Spanish] [Chinese] [Vietnamese] Updated January 01, 2023
State Fair Hearing Form - [English] [Spanish] [Chinese] [Vietnamese] Updated September 01, 2021
Coverage Decision Letter - Claims
English
Last Updated: 11/22/2022
Spanish
Last Updated:11/22/2022
Chinese
Last Updated:11/22/2022
Vietnamese
Last Updated:11/22/2022
Nondiscrimination Notice, Taglines, Language Insert - [English] [Spanish] [Chinese] [Vietnamese] Updated February 21, 2023
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Medicare
Certificates of Medical Necessity (CMN) & DME Information Forms (DIF)
Positive Airway Pressure Devices for Obstructive Sleep Apnea (PDF)
Enteral and Parenteral Nutrition (PDF)
External Infusion Pump (PDF)
Osteogenesis Stimulators (PDF)
Oxygen (PDF)
Seat Lift Mechanisms (PDF)
Continuation Form (PDF)
Transcutaneous Electrical Nerve Stimulator (TENS) (PDF)
Pneumatic Compression Device (PDF)
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Non-Contracted Providers
To submit a referral to IEHP, please fill out the referral form below, include all clinical notes and fax it to IEHP. If you are referring back to yourself, please indicate such. If you need IEHP to direct the referral, please indicate that on the form.
Referral Authorization Request Form - Non-Contracted Providers (PDF)
If you are interested in becoming a network Provider, please click here.
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Perinatal
IEHP provides standard risk assessment forms that can be used by all Providers of obstetrical (OB) services. Please refer to IEHP Provider Policy 10D1, "Obstetrical Services, Guidelines for Obstetrical Services" for further detail. To obtain copies, simply click on the links below.
Edinburgh Postnatal Depression Screening Tool - English (PDF)
Edinburgh Postnatal Depression Screening Tool - Spanish (PDF)
ACOG Antepartum Record (PDF)
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Pharmacy
Click here for Pharmacy forms.
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Provider Preventable Conditions (PPC)
By clicking on these links, you will be leaving the IEHP website.
On May 23,2017, the Department of Healthcare Services (DHCS) released All Plan Letter (APL) 17-009, reporting requirements related to Provider Preventable Conditions. In conjunction, DHCS released Dual Plan Letter (DPL) 17-002. As part of these instructions, the Health Plan, Network Providers, Delegates, Contracted Hospitals, and ambulatory surgical centers must report using PPC Form on DHCS secure online portal for both Medicare and Medi-Cal lines of business.
Further information is available on the following pages:
Instructions for Completing Online Reporting of PPCs
Medi-Cal Guidance on Reporting Provider-Preventable Conditions
Frequently Asked Questions
All Plan Letter (APL) 17-009
Duals Plan Letter (DPL) 17-002
PPC Form
Medicare and Medi-Cal lines of business must follow the instructions below:
Providers are REQUIRED to send a copy of the completed PPC submission from the DHCS secure online portal to IEHP by fax at (909) 890-5545 within five (5) business days of reporting to DHCS;
IEHP does not pay Provider claims nor reimburse a Provider for a PPC, in accordance with 42 CFR Section 438.3(g) and IEHP's three-way Cal MediConnect contract. Per IEHP policy and the Coordinated Care Initiative 3-Way Contract, IEHP reserves the right to recover or recoup any claim related to a PPC;
As outlined in both the APL/DPL - Reporting Requirements related to Provider Preventable Conditions, the following classify as PPCs and must be reported:
Category 1 - HCACs (For Any Inpatient Hospital Setting in Medicaid)
Any unintended foreign object retained after surgery
A clinically significant air embolism
An incidence of blood incompatibility
A stage III or stage IV pressure ulcer that developed during the patient's stay in the hospital
A significant fall or trauma that resulted in fracture, dislocation, intracranial injury, crushing injury, burn, or electric shock
A catheter-associated urinary tract infection
Vascular catheter-associated infection
Any of the following manifestations of poor glycemic control: diabetic ketoacidosis; nonketotic hyperosmolar coma; hypoglycemic coma; secondary diabetes with ketoacidosis; or secondary diabetes with hyperosmolarity
A surgical site infection following:
Coronary artery bypass graft (CABG) - mediastinitis
Bariatric surgery; including laparoscopic gastric bypass, gastroenterostomy, laparoscopic gastric restrictive surgery
Orthopedic procedures; including spine, neck, shoulder, elbow
Cardiac implantable electronic device procedures
Deep vein thrombosis/pulmonary embolism following total knee replacement or hip replacement with pediatric and obstetric exceptions
Latrogenic pneumothorax with venous catheterization
A vascular catheter-associated infection
Category 2 - Other Provider Preventable Conditions (For Any Health Care Setting)
Wrong surgical or other invasive procedure performed on a patient
Surgical or other invasive procedure performed on the wrong body part
Surgical or other invasive procedure performed on the wrong patient
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UM/CM
Acute Hospital Discharge Needs Request Form (PDF)
Authorization for Use and/or Disclosure of Patient Health Information - English (PDF)
Authorization for Use and/or Disclosure of Patient Health Information - Spanish (PDF)
Care Management Referral Form (PDF)
Consent for HIV Test - English (PDF)
Consent for HIV Test - Spanish (PDF)
Health Risk Assessment (HRA) - IEHP DualChoice (CMC) - English (PDF)
Health Risk Assessment (HRA) - IEHP DualChoice (CMC)- Spanish (PDF)
Health Risk Assessment (HRA) - IEHP DualChoice (HMO D-SNP) - English (PDF) - effective 1/1/2023
Health Risk Assessment (HRA) - IEHP DualChoice (HMO D-SNP) - Spanish (PDF) - effective 1/1/2023
Health Risk Assessment (HRA) - IEHP DualChoice (HMO D-SNP) - Chinese (PDF) - effective 1/1/2023
Health Risk Assessment (HRA) - IEHP DualChoice (HMO D-SNP) - Vietnamese (PDF) - effective 1/1/2023
HIV Testing Sites - Riverside and San Bernardino (PDF)
Home Health Check Off List (PDF)
Home Modification Consent Form (PDF)
Long Term Care (LTC) Data Sheet (PDF)
Non-Emergency Medical Transportation (NEMT) Physician Certification Statement (PCS) (PDF)
Referral Form (PDF)
Service Request for Skilled Nursing Facilities (PDF)
SNF Initial Review (PDF)
SNF Follow-up Review (PDF)
Standing Referral and Extended Access Referral to Specialty Care (PDF)
Sterilization Consent Form PM-330
PM-330 Form - Tips and Example (PDF)
PM-330 Form - English (PDF)
PM-330 Form - Spanish (PDF)
Transportation Requests Form (SNF & LTC) (PDF)
Transportation Requests Form (Hospital) (PDF)
Wound Assessment - Admission (PDF)
Wound Assessment - Follow - Up (PDF)
Wound Assessment - Addendum (PDF)
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Vision
Ophthalmologist Referral Form (PDF)
Vision Exception Request (VER) Form (PDF)
PCP Vision Report Form (PDF)
IEHP Lab Form (PDF)
Medi-Cal Non-Covered Services/Materials Waiver Form-English (PDF)
Medi-Cal Non-Covered Services/Materials Waiver Form-Spanish (PDF)
Medi-Cal Non-Covered Services/Materials Waiver Form-Chinese (PDF)
Medi-Cal Non-Covered Services/Materials Waiver Form-Vietnamese (PDF)
The following IEHP DualChoice (HMO D-SNP) Letters will be effective January 1, 2023:
IEHP DualChoice (HMO D-SNP) Non-Covered Services/Materials Waiver Form-English (PDF)
IEHP DualChoice (HMO D-SNP) Non-Covered Services/Materials Waiver Form-Spanish (PDF)
IEHP DualChoice (HMO D-SNP) Non-Covered Services/Materials Waiver Form-Chinese (PDF)
IEHP DualChoice (HMO D-SNP) Non-Covered Services/Materials Waiver Form-Vietnamese (PDF)
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Other
Authorization of Release - Use & Disclosure of PHI - English (PDF)
Authorization of Release - Use & Disclosure of PHI - Spanish (PDF)
CMS 1696 Appointment of Representative - English (PDF)
CMS 1696 Appointment of Representative - Spanish (PDF)
Contracts Maintenance Request Form (PDF)
Provider Services Materials Request Form (PDF)
2017 Model Output Report (MOR) Data File Layout (PDF)
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You will need Adobe Acrobat Reader 6.0 or later to view the PDF files. You can download a free copy by clicking here.
Renueve su cobertura de Medi-Cal
año para mantener los beneficios. Una vez al año, recibirá una carta por correo en la que dirá si el condado renovó automáticamente su Medi-Cal o si necesitan más información. Es importante que lea esa carta y siga las instrucciones. ¿Qué información pedirá el condado? Formularios de renovación completados Verificación (como una copia de su recibo de pago) Actualizaciones de su información de contacto Si su condado le pide más información, deberá dársela antes de la fecha prevista. Si no responde antes de la fecha prevista, sus beneficios de Medi-Cal podrían terminar. ¿Cómo puede entregar esta información? Puede presentar la información en línea, por correo, en persona o por teléfono. Hágalo en línea: Cree su cuenta en línea hoy mismo visitando BenefitsCal.com y haciendo clic en el enlace “Create an Account” (Crear una cuenta). Para obtener más información, vea el video: “BenefitsCal: How to Create an Account” (BenefitsCal: cómo crear una cuenta) Si ya tiene una cuenta de BenefitsCal.com, puede enviar la información siguiendo los pasos en este video: “BenefitsCal How to Submit a Medi-Cal Renewal” (BenefitsCal, cómo presentar una renovación de Medi-Cal). Envíe el paquete por correo a la oficina del condado. Vaya en persona a la oficina: Llame a la oficina: Condado de Riverside: 1-877-410-8827, lunes – viernes, 8am – 5pm Condado de San Bernardino: 1-877-410-8829, lunes – viernes, 7am – 5pm ¿Qué pasa si no cumple el plazo? Comuníquese con el condado para ver si de todos modos puede enviar sus documentos. ¿Con quién puede hablar si tiene preguntas? Si necesita más ayuda, llame a IEHP al 1-888-860-1296, lunes – viernes, 8am – 5pm o a la oficina de Medi-Cal de su condado: Condado de Riverside: 1-877-410-8827, lunes – viernes, 8am – 5pm Condado de San Bernardino: 1-877-410-8829, lunes – viernes, 7am – 5pm ¿Qué pasará después de que complete y presente la información? Recibirá una carta del condado una vez que sus documentos se hayan revisado. ¿Acaba de mudarse? ¿Qué información necesita darle al condado? Comuníquese con la oficina del condado para asegurarse de que tengan información actualizada sobre usted y su familia, incluyendo: Nombre actual Dirección Número de teléfono Dirección de email El condado necesita esto para comunicarse con usted para darle información importante sobre su Medi-Cal.
Política de Privacidad
emos que los visitantes a iehp.org necesitan estar en control de su información personal.
De manera que, enseguida verá la Norma de Privacidad en Internet de IEHP:
Usted no tiene que darnos su información personal para poder visitar nuestro sitio. Si usted opta por no proporcionar sus datos personales, aún así, puede visitar a iehp.org.
Archivos Implantados (Cookies)
¿Qué es un archivo implantado?
Un archivo implantado es un pequeño segmento de información que se envía a su buscador (browser) – junto con la página del sitio – cuando usted accesa una página de sitio.
Existen dos tipos de archivos implantados. Un archivo implantado de sesión, es una línea de texto que se almacena temporalmente en la memoria de su computadora. Puesto que un archivo implantado de sesión nunca se guarda, se destruye tan pronto cierra usted su hojeador y buscador. Un archivo implantado persistente es una línea de texto más permanente que su hojeador y buscador guarda en un archivo de su disco duro.
IEHP utiliza únicamente archivos implantados de sesión. Nosotros no utilizamos archivos implantados persistentes.
El Uso de Archivos Implantados de IEHP
Ciertas aplicaciones en los sitios en la Red de iehp.org requieren de archivos implantados de sesión para poder funcionar correctamente. Si usted ha desactivado los archivos implantados de sesión, puede ser que usted no pueda usar esas aplicaciones o características de nuestros sitios.
En los lugares que se ocupan, los archivos implantados de sesión de IEHP recuerdan su criterio de selección. Por ejemplo, si usted usa la versión "Screen Reader Friendly" de iehp.org con los archivos implantados desactivados, usted tendrá que escoger esta opción para cada página. Si usted tiene activado su archivo implantado, esta preferencia será recordada por la duración de su visita.
No es necesario que usted tenga activado su archivo implantado de sesión para ver el contenido estático del sitio iehp.org.
Hemos programado nuestro software para que su hojeador y buscador solo devuelva información del archivo implantado a iehp.org. Ningún otro sitio lo puede solicitar.
Nota: A pesar de los usos particulares de los archivos implantados en los sitios de IEHP en la red, no compartiremos la información de esos archivos implantados con terceros.
Enlace a otros Sitios
De vez en cuando proporcionamos enlaces a otros sitios en la red que no son propiedad ni controlados por IEHP. Esto lo hacemos porque creemos que esta información pueda ser de interés o útil para usted; o en casos donde a usted, como Miembro, le podemos proporcionar información adicional y/o servicios.
Mientras ponemos todo nuestro empeño para asegurar su privacidad, no podemos responsabilizarnos de las prácticas de privacidad de otros sitios. Un enlace a un sitio en la Red que no sea IEHP no constituye ni implica que IEHP lo respalde.
Adicionalmente, no podemos garantizar la calidad ni la precisión de la información presentada en los sitios en la Red que no son de IEHP. Le recomendamos que revise las prácticas de privacidad de cualquier sitio en la Red que usted visite.
El sitio en la red de IEHP muestra claramente cuándo es que un Usuario está dejando el sitio en la red para conectarse al sitio de enlace.
¿Cómo Será Utilizada la Información que ha sido Recopilada Acerca de Mí?
Podríamos recabar información que lo identifique personalmente (nombre, correo electrónico, domicilio habitual, y otros identificadores particulares) sólo si es específica y conscientemente proporcionada por usted.
La información recabada que lo identifique personalmente, como lo es la información que usted nos brinda cuando presente una queja de agravio, será utilizada sólo en conexión con iehp.org, o para aquellos propósitos que se describan al momento de recabarlos.
IEHP protegerá la información personal que usted comparta con nosotros. IEHP no revela, regala, vende ni transfiere cualquier dato personal, a terceros. Si compartimos los datos demográficos con terceros, les daremos únicamente datos agregados.
Los datos recabados son sólo para propósitos de estadísticas. IEHP efectúa análisis de conducta del usuario para poder medir los intereses de sus Miembros en las diversas áreas de nuestros sitios.
Para hacer cambios en los datos que usted nos haya proporcionado en línea, llame a los Servicios para Miembros de IEHP al 1-800-440-IEHP (4347)/TTY (909) 890-0731.
Nosotros administramos y conservamos los datos obtenidos de salud personal durante seis años, cumpliendo con los reglamentos federales y estatales. Las eliminaciones y/o retiros se tratan cumpliendo con las Normas y Procedimientos de Agravios: Eliminaciones y Retiros.
Uso de Correo Electrónico
A pesar de que IEHP haga todos los esfuerzos por proteger la información personal que usted comparte con nosotros, el correo electrónico no está protegido contra intercepción. Si su comunicación es muy sensible, puede ser que desee enviarla mejor por correo. O llame a los Servicios para Miembros de IEHP al 1-800-440-IEHP (4347)/TTY (909) 890-0731.
Queremos ser muy claros: No obtendremos datos suyos que lo identifiquen personalmente cuando usted visite nuestro sitio, a no ser que usted decida proporcionar dicha información voluntariamente.
El correo electrónico que envíe a los Servicios para Miembros al memberservices@iehp.org tendrá respuesta en menos de 24 horas.
Las quejas de agravio presentadas en línea, serán reconocidas por escrito en menos de 5 días calendarios.
Solicitud de Normas y Procedimientos
Usted puede revisar nuestras Normas y Procedimientos donde se detallan las normas editoriales, la seguridad, la responsabilidad y el acceso en línea, o puede solicitar una copia llamando a los Servicios para Miembros de IEHP.
Cambios a Nuestra Declaración de Privacidad en la Red
La Declaración de Privacidad en la Red que precede, la cual entró en vigor el 1 de Septiembre de 2002, fue revisada en ocho de julio, 2004.
IEHP puede hacer cambios a esta declaración de vez en cuando sin previo aviso. Esta declaración no es con el fin de crear, y de hecho no crea algún derecho contractual u otro legal, ni por, ni para alguna de las partes.
Nuevamente, esperamos que disfrute y que sea segura su experiencia en línea. Gracias por tomarse el tiempo para leer esta Declaración de Privacidad.
Puntos agregados al Aviso de Privacidad
Mensajes y operaciones
Los comentarios o preguntas que nos envíe por correo electrónico o mediante formularios de mensajería segura se pueden comunicar al personal de IEHP y a los profesionales de la salud que mejor pueden resolver sus inquietudes. Archivaremos sus mensajes después de haber hecho todo lo posible para brindarle una respuesta completa y satisfactoria. Todo el personal de IEHP trata la información de los miembros en forma confidencial. Su privacidad es una prioridad para IEHP.
Cuando usted utilice un servicio en la sección segura de este sitio Web para interactuar en forma directa con los profesionales de la salud de IEHP, parte de la información que proporcione se podrá documentar en su historia clínica y podrá estar disponible como guía para su tratamiento como paciente.
Niños
No permitimos que, dentro de nuestro conocimiento, los miembros de IEHP menores de 18 años creen cuentas que les den acceso a las funciones seguras de este sitio.
Opción de retiro
Si un usuario solicita recibir información en forma continua a través de este sitio Web y nos proporciona su dirección de correo electrónico (por ejemplo, solicitud de suscripción a una de nuestras publicaciones en línea), podrá solicitar que se interrumpa el envío de correo en el futuro. De manera similar, si usted recibe información sobre un servicio de IEHP vía correo electrónico, puede solicitar que el envío de mensajes similares se interrumpa en el futuro. Todos los materiales que se le envíen vía correo electrónico tendrán información sobre la manera de elegir no recibirlos.
Para dejar de recibir información de IEHP vía correo electrónico, ingrese a su cuenta de miembro. Seleccione la opción “Actualizar perfil” (“Update Profile”) y quite el tilde en la casilla que indica “Contacto por correo electrónico” (“Email Contact”) (repita el procedimiento para cada miembro de su familia).
Además, si se registra como miembro para usar funciones seguras de nuestro sitio Web, puede tener la oportunidad de recibir información vía correo electrónico sobre los diferentes tipos de productos, servicios, anuncios y actualizaciones de IEHP. Usted puede cambiar sus preferencias en cualquier momento llamando a Servicios al Miembro de IEHP al 1-800-440-IEHP.
Protéjase de fraudes por correo electrónico llamados “phishing” (correos fraudulentos) o “spoof” (correos falsos)
Proteger la privacidad de los miembros es una prioridad de IEHP. También alentamos enérgicamente a nuestros miembros a que tomen todas las precauciones para resguardar su información personal contra los fraudes vía correo electrónico conocidos como mensajes tramposos para el robo de identidad (“phishing”).
Los correos electrónicos falsos o destinados al robo de identidad son dos mecanismos diferentes, pero interrelacionados, que utilizan las personas que quieren cometer un fraude para robar su información personal. El envío de correos falsos se refiere a la práctica de “hacerse pasar” por otra persona en un mensaje de correo electrónico o en Internet. El envío de correos tramposos destinados al robo de identidad es un intento de engañar a los usuarios para que revelen su información privada, por lo general conjuntamente con un correo falso y una página Web.
¿Qué es el envío de correos tramposos para el robo de identidad?
Esta práctica está diseñada para robar la identidad. A través de correos electrónicos fraudulentos ocultos en la forma de correos electrónicos de empresas legítimas, los delincuentes intentan engañar a las personas para que proporcionen información personal, como números de tarjetas de crédito, contraseñas, datos de cuentas u otra información de valor.
¿Cómo funciona esta práctica?
En los correos electrónicos generalmente aparecen los nombres de marcas conocidas, como su banco, su compañía de seguro o incluso su proveedor de telefonía inalámbrica. Estos correos engañosos se llaman “correos electrónicos falsos” (“spoof”) porque imitan la apariencia de un sitio Web o compañía conocidos para intentar robar su identidad. Normalmente, estos mensajes intentan crear una idea de urgencia y solicitan a la persona que los recibe que actualice o confirme su información personal. Es posible que se proporcionen enlaces a un sitio Web que también puede exhibir el logo de la compañía u otros de sus elementos conocidos.
A qué debe prestar atención:
Saludos generales. En lugar de usar su nombre, muchos correos electrónicos fraudulentos comienzan con un saludo general, como: “Estimado cliente de [Nombre de la empresa]”.(IEHP siempre enviará correos electrónicos que incluyan su número de identificación de miembro o su nombre completo).
Una falsa idea de urgencia. El mensaje intentará engañarlo con la amenaza de que su cuenta corre peligro si no actualiza su información lo antes posible.
Enlaces falsos. El texto de un enlace puede parecer válido y luego lo remitirá a una dirección falsa. Siempre debe verificar el lugar adonde lo remite un enlace antes de hacer clic en él. Mueva el mouse sobre el enlace y mire la dirección URL en su navegador o barra de estado. Si parece sospechoso, no haga clic en el enlace.
¿Qué ocurre si recibo un correo electrónico fraudulento o que parece serlo? Le sugerimos que no responda ese mensaje o a la dirección de correo electrónico que aparece en el cuerpo del mensaje. Si recibe un correo electrónico sospechoso que afirma ser de IEHP, llame de inmediato a Servicios al Miembro de IEHP al 1-800-440-IEHP.
Adopte buenas medidas generales de seguridad al usar la computadora. Estas medidas incluyen instalar y mantener un programa antivirus y un firewall. Algunos correos electrónicos fraudulentos destinados al robo de información personal contienen mecanismos espías (“spyware”) que pueden rastrear su actividad en Internet y poner en peligro la seguridad de su sistema.
Nota: IEHP no envía avisos por correo electrónico para solicitar información de pago del cliente, el nombre de usuario o las contraseñas usadas para manejar la cuenta.
Para más información sobre IEHP
Presione el botón en “Acerca de IEHP” de nuestra página de portada para conocer al equipo de administración, o para revisar los informes de la junta.
MediCal - Community Supports
ffer in place of services or settings covered under the Medicaid State Plan. These services should be medically appropriate and cost-effective alternatives.
Beginning January 1, 2022, Inland Empire Health Plan (IEHP) is offering 11 of the 14 DHCS Preapproved Community Supports services:
Asthma Remediation
Community Transition Services/Nursing Facility Transition to a Home
Home Modifications
Housing Deposits
Housing Tenancy and Sustaining Services
Housing Transition Navigation Services
Medically Supportive Food/Meals/Medically Tailored Meals
Nursing Facility Transition/Diversion to Assisted Living Facilities, such as Residential Care
Recuperative Care (Medical Respite)
Short-Term Post-Hospitalization Housing
Sobering Centers (Riverside County)
Tentative Upcoming Services
Day Habilitation (Date TBD)
Personal Care and Homemaker Services (Date TBD)
Respite Services (Date TBD)
Community Supports FAQs (PDF)
Please return the completed Community Supports Service Provider Assessment (PDF) via email at DGCommunitySupportTeam@iehp.org.
You will need Adobe Acrobat Reader 6.0 or later to view the PDF files. You can download a free copy by clicking here.
IEHP DualChoice - Problemas con la Parte C
bertura y la presentación de apelaciones por problemas relacionados con sus beneficios y cobertura. También incluye problemas con el pago. Usted no es responsable por los costos de Medicare, excepto los copagos de la Parte D.
¿Cómo se pide una decisión de cobertura para obtener servicios médicos, servicios de salud conductual o determinados servicios y apoyo de largo plazo (CBAS o servicios NF)?
Para pedir una decisión de cobertura, llámenos, escríbanos o envíenos un fax o pídale a su representante o doctor que nos pida una decisión de cobertura.
Puede llamarnos al: (877) 273-IEHP (4347), 8am – 8pm (hora del Pacífico), los 7 días de la semana, incluyendo los feriados, TTY (800) 718-4347.
Puede enviarnos un fax al: (909) 890-5877
Puede escribirnos a:
IEHP DualChoice
P.O. Box 1800
Rancho Cucamonga, CA 91729-1800.
¿Cuánto tiempo lleva obtener una decisión de cobertura para servicios de la Parte C?
Normalmente lleva hasta 14 días consecutivos después de haberla pedido. Si no le damos nuestra decisión en un plazo de 14 días consecutivos, puede apelar.
A veces necesitamos más tiempo, y le enviaremos una carta en la que le avisaremos que necesitamos tomarnos hasta 14 días consecutivos adicionales. La carta explicará por qué se necesita más tiempo.
¿Puedo obtener una decisión de cobertura más rápido para servicios de la Parte C?
Sí. Si necesita una respuesta más rápida debido a su salud, debería pedirnos que tomemos una “decisión rápida de cobertura rápida”. Si aprobamos la solicitud, lo informaremos de nuestra decisión de cobertura en un plazo de 72 horas. Sin embargo, a veces necesitamos más tiempo, y le enviaremos una carta en la que le avisaremos que necesitamos tomarnos hasta 14 días consecutivos adicionales.
Cómo pedir una decisión de cobertura rápida:
Si pide una decisión de cobertura rápida, comience llamando o enviando por fax a nuestro plan para pedirnos que cubramos la atención médica que quiere.
Puede llamar a IEHP DualChoice al (877) 273-IEHP (4347), 8am – 8pm (hora del Pacífico), los 7 días de la semana, incluyendo los feriados. Los usuarios de TTY deben llamar al (800) 718-4347 o enviarnos un fax al (909) 890-5877.
También puede hacer que su doctor o su representante nos llame.
Estas son las normas para pedirnos una decisión de cobertura rápida:
Debe cumplir los siguientes dos requisitos para obtener una decisión de cobertura rápida:
Puede obtener una decisión de cobertura rápida solamente si está pidiendo cobertura para atención médica o un artículo que todavía no ha recibido. (No puede obtener una decisión de cobertura rápida si su solicitud se trata del pago de atención médica o un artículo que ya ha recibido).
Puede obtener una decisión de cobertura rápida solo si el plazo de 14 días consecutivos causaría un daño grave a su salud, o si su capacidad para funcionar se vería afectada.
Si su doctor dice que necesita una decisión de cobertura rápida, le daremos una automáticamente.
Si usted pide una decisión de cobertura rápida, sin el apoyo de su doctor, decidiremos si obtendrá una decisión de cobertura rápida o no.
Si decidimos que su salud no cumple los requisitos para una decisión de cobertura rápida, le enviaremos una carta. También usaremos el plazo estándar de 14 días consecutivos en su lugar.
Esta carta le dirá que si su doctor pide la decisión de cobertura rápida, le daremos automáticamente una decisión de cobertura rápida.
La carta también le dirá cómo puede presentar una “apelación rápida” sobre nuestra decisión de darle una decisión de cobertura en lugar de la decisión de cobertura rápida que solicitó.
Si la decisión de cobertura es “Sí”, ¿cuándo recibiré el servicio o artículo?
Podrá recibir el servicio o artículo en un plazo de 14 días consecutivos (para una decisión de cobertura estándar) o 72 horas (para una decisión de cobertura rápida) después de su solicitud. Si necesitamos más tiempo para tomar nuestra decisión de cobertura, le daremos la cobertura al final de ese período ampliado.
Si la decisión de cobertura es “No”, ¿cómo me enteraré?
Si la respuesta es “No”, le enviaremos una carta en la que le diremos nuestros motivos por los que la respuesta es “No”.
Si decimos que no, usted tiene derecho a pedirnos que modifiquemos esta decisión mediante una apelación. Hacer una apelación significa pedirnos que revisemos nuestra decisión de denegar la cobertura.
Si decide hacer una apelación, significa que recurrirá al Nivel 1 del proceso de apelación.
Apelaciones
¿Qué es una Apelación?
Una apelación es una manera formal de pedirnos que revisemos nuestra decisión y la modifiquemos si usted cree que hemos cometido un error. Por ejemplo, podemos decidir que un servicio, artículo o medicamento que usted quiere no está cubierto o ya no está cubierto por Medicare o Medi-Cal. Si usted o su doctor no están de acuerdo con nuestra decisión, pueden apelar.
En la mayoría de los casos, debe iniciar su apelación en el Nivel 1. Si no quiere hacer primero una apelación al plan por un servicio de Medi-Cal, en casos especiales puede pedir una revisión médica independiente. Si necesita ayuda durante el proceso de apelaciones, puede llamar a la Oficina del Ombudsman al 1-888-452-8609. La Oficina del Ombudsman no tiene ninguna conexión con nosotros ni con ninguna compañía de seguros o plan médico.
¿Qué es una Apelación de Nivel 1 para los servicios de la Parte C?
Una Apelación de Nivel 1 es la primera apelación a nuestro plan. Revisaremos nuestra decisión de cobertura para ver si es correcta. El revisor será una persona que no tomó la decisión de cobertura original. Cuando terminemos la revisión, le comunicaremos nuestra decisión por escrito. Si le decimos después de nuestra revisión que el servicio o artículo no están cubiertos, su caso puede pasar a una Apelación de Nivel 2.
¿Puede otra persona hacer la apelación por mí para los servicios de la Parte C?
Sí. Su doctor u otro proveedor pueden hacer la apelación por usted. También, otra persona además de su doctor u otro proveedor pueden hacer la apelación por usted, pero primero debe contestar un Formulario de designación de representante. El formulario le da a la otra persona permiso para que actúe en su nombre.
Si la apelación proviene de alguien que no es usted o su doctor u otro proveedor, debemos recibir el formulario de designación de representante completado para poder revisar la apelación.
¿Cómo hago una Apelación de Nivel 1 por servicios de la Parte C?
Para comenzar su apelación, usted, su doctor u otro proveedor o su representante deben comunicarse con nosotros. Puede llamar a Servicios para Miembros de IEHP DualChoice al (877) 273-IEHP (4347), 8am – 8pm (hora del Pacífico), los 7 días de la semana, incluyendo feriados. Los usuarios de TTY deben llamar al (800) 718-4347. Para obtener información adicional sobre cómo comunicarse con nosotros para las apelaciones, consulte el Capítulo 9 del Manual para Miembros de IEHP DualChoice.
Puede pedirnos una “apelación estándar” o una “apelación rápida”.
Si pide una apelación estándar o una apelación rápida, preséntela por escrito:
IEHP DualChoice
P.O. Box 1800
Rancho Cucamonga, CA 91729-1800
Fax: (909) 890-5748
También puede pedir una apelación llamando a Servicios para Miembros de IEHP DualChoice al (877) 273-IEHP (4347), 8am – 8pm (hora del Pacífico), los 7 días de la semana, incluyendo feriados. Los usuarios de TTY deben llamar al (800) 718-4347.
Le enviaremos una carta en un plazo de 5 días consecutivos después de recibir su apelación, en la que lo informaremos de que la hemos recibido.
¿Cuánto tiempo tengo para hacer una apelación por servicios de la Parte C?
Debe pedir una apelación en un plazo de 60 días consecutivos después de la fecha de la carta que le enviamos para informarlo de nuestra decisión.
Si no cumple este plazo por un buen motivo, es posible que le demos más tiempo para hacer la apelación. Algunos ejemplos de un buen motivo son si tuvo una enfermedad grave o le dimos la información equivocada sobre el plazo para pedir una apelación.
¿Puedo obtener una copia del expediente de mi caso?
Sí. Pídanos una copia llamando a Servicios para Miembros al (877) 273-IEHP (4347). TTY (800) 718-4347.
¿Puede mi doctor darles más información sobre mi apelación por servicios de la Parte C?
Sí, usted y su doctor pueden darnos más información para apoyar su apelación.
¿Cómo tomará el plan la decisión de apelación?
Revisamos con atención toda la información sobre su solicitud de cobertura de atención médica. Luego, verificamos si seguimos todas las normas cuando respondimos que “No” a su solicitud. El revisor será una persona que no tomó la decisión original. Si necesitamos más información, es posible que se la pidamos a usted o a su doctor.
¿Cuándo me enteraré de una decisión de apelación “estándar” por servicios de la Parte C?
Debemos darle nuestra respuesta en un plazo de 30 días consecutivos después de recibir su apelación. Le daremos nuestra decisión lo antes posible si su afección requiere que lo hagamos.
Sin embargo, si pide más tiempo o si necesitamos obtener más información, podemos tomarnos hasta 14 días consecutivos adicionales. Si decidimos tomarnos días adicionales para tomar la decisión, se lo avisaremos por carta.
Si cree que no deberíamos tomarnos días adicionales, puede presentar una “queja rápida” sobre nuestra decisión de tomarnos días adicionales. Cuando presente una queja rápida, le daremos una respuesta a su apelación en un plazo de 24 horas.
Si no le damos una respuesta en un plazo de 30 días consecutivos o al final de los días adicionales (si los tomamos), enviaremos automáticamente su caso al Nivel 2 del proceso de apelaciones si su problema trata de un servicio o artículo de Medicare. Lo informarán de esto cuando suceda. Si su problema es por un servicio o artículo de Medi-Cal, tendrá que presentar una Apelación de Nivel 2 usted mismo. Abajo encontrará más información.
Si nuestra respuesta es “Sí” a una parte o la totalidad de lo que pidió, debemos aprobar o dar la cobertura en un plazo de 30 días consecutivos después de haber recibido su apelación.
Si nuestra respuesta es “No” a una parte o a todo lo que pidió, le enviaremos una carta. Si su problema trata de un servicio o artículo de Medicare, la carta le dirá que hemos enviado su caso a la Entidad de Revisión Independiente para una Apelación de Nivel 2. Si su problema trata de un servicio o artículo de Medi-Cal, la carta le dirá cómo presentar una Apelación de Nivel 2 usted mismo. Abajo encontrará más información.
¿Qué pasa si pido una apelación rápida?
Si pide una apelación rápida, le daremos la respuesta en un plazo de 72 horas después de recibir su apelación. Le daremos nuestra decisión lo antes posible si su salud requiere que lo hagamos.
Sin embargo, si pide más tiempo o si necesitamos obtener más información, podemos tomarnos hasta 14 días consecutivos adicionales. Si decidimos tomarnos días adicionales para tomar la decisión, se lo avisaremos por carta.
Si cree que no deberíamos tomarnos días adicionales, puede presentar una “queja rápida” sobre nuestra decisión de tomarnos días adicionales. Cuando presente una queja rápida, le daremos una respuesta a su apelación en un plazo de 24 horas.
Si no le damos una respuesta en un plazo de 72 horas o al final de los días adicionales (si los tomamos), enviaremos automáticamente su caso al Nivel 2 del proceso de apelaciones si su problema trata de un servicio o artículo de Medicare. Lo informarán de esto cuando suceda. Si su problema es por un servicio o artículo de Medi-Cal, tendrá que presentar una Apelación de Nivel 2 usted mismo. Abajo encontrará más información.
Si nuestra respuesta es “Sí” a una parte o a todo lo que pidió, debemos autorizar o dar la cobertura en un plazo de 72 horas después de haber recibido su apelación.
a una parte o a todo lo que pidió, le enviaremos una carta. Si su problema trata de un servicio o artículo de Medicare, la carta le dirá que hemos enviado su caso a la Entidad de Revisión Independiente para una Apelación de Nivel 2. Si su problema trata de un servicio o artículo de Medi-Cal, la carta le dirá cómo presentar una Apelación de Nivel 2 usted mismo. Abajo encontrará más información.
¿Continuarán mis beneficios durante las apelaciones de Nivel 1?
Si decidimos modificar o suspender la cobertura de un servicio o artículo que se había aprobado antes, le enviaremos un aviso antes de tomar la resolución. Si no está de acuerdo con la acción, puede presentar una Apelación de Nivel 1 y pedir que continuemos sus beneficios para el servicio o artículo. Debe hacer la solicitud en uno de los siguientes momentos o antes del que sea posterior para que sus beneficios continúen:
en un plazo de 10 días desde la fecha de envío por correo de nuestro aviso de resolución; o
en la fecha de vigencia prevista de la resolución.
Si cumple este plazo, puede seguir recibiendo el servicio o artículo en disputa mientras se esté procesando su apelación.
Apelación de Nivel 2
Si el plan dice que “No” en el Nivel 1, ¿qué sucede después?
Si decimos que no a una parte o a toda su Apelación de Nivel 1, le enviaremos una carta. Esta carta le dirá si el servicio o artículo suele estar cubierto por Medicare o Medi-Cal.
Si su problema trata de un servicio o artículo de Medicare, enviaremos automáticamente su caso al Nivel 2 del proceso de apelaciones apenas se complete la Apelación de Nivel 1.
Si su problema trata de un servicio o artículo de Medi-Cal, puede presentar una Apelación de Nivel 2 usted mismo. En la carta se lo informará de cómo hacer esto. También hay información abajo.
¿Qué es una Apelación de Nivel 2?
Una Apelación de Nivel 2 es la segunda Apelación, y la hace una organización independiente que no tiene conexión con el plan.
Mi problema trata de un servicio o artículo de Medi-Cal. ¿Cómo puedo hacer una Apelación de Nivel 2?
Hay dos formas de hacer una apelación de Nivel 2 por servicios y artículos de Medi-Cal: 1) Revisión médica independiente o 2) Audiencia estatal.
1) Revisión médica independiente
Puede pedir una revisión médica independiente (IMR) del Centro de Ayuda del Departamento de Administración de Servicios Médicos de California (DMHC). Se puede hacer una IMR por cualquier servicio o artículo cubierto de Medi-Cal que sea de naturaleza médica. Una IMR es una revisión de su caso hecha por doctores que no son parte de nuestro plan. Si la decisión de la IMR es a su favor, debemos darle el servicio o artículo que solicitó. Usted no tiene que pagar ningún costo por una IMR.
Puede solicitar una IMR si nuestro plan:
Deniega, modifica o retrasa un servicio o tratamiento de Medi-Cal (sin incluir IHSS) porque nuestro plan determina que no es médicamente necesario.
No cubrirá un tratamiento de experimentación o investigación de Medi-Cal para una afección médica grave.
No pagará servicios de emergencia o urgencia de Medi-Cal que ya ha recibido.
No ha resuelto su Apelación de Nivel 1 sobre un servicio de Medi-Cal en un plazo de 30 días consecutivos para una apelación estándar o 72 horas para una apelación rápida.
Puede pedir una IMR si también ha pedido una audiencia estatal, pero no si ya ha pedido una audiencia estatal sobre la misma cuestión.
En la mayoría de los casos, debe presentar una apelación ante nosotros antes de pedir una IMR. Si no está de acuerdo con nuestra decisión, puede pedirle una IMR al Centro de Ayuda del DMHC.
Si le denegaron el tratamiento porque era de experimentación o investigación, no es necesario que participe en nuestro proceso de apelación antes de pedir una IMR.
Si su problema es urgente y representa una amenaza inmediata y grave para su salud, puede informar de inmediato al DMHC de ello. Es posible que el DMHC no exija que primero siga nuestro proceso de apelación en casos extraordinarios y convincentes.
Debe pedir una IMR en un plazo de 6 meses después de que le enviemos una decisión por escrito sobre su apelación. El DMHC podrá aceptar su solicitud después de los 6 meses si determina que hubo circunstancias que le impidieron presentar su solicitud a tiempo.
Para pedir una IMR:
Conteste el Formulario de revisión médica independiente/queja disponible en: http://www.dmhc.ca.gov/FileaComplaint/SubmitanIndependentMedicalReviewComplaintForm.aspx o llame al Centro de Ayuda del DMHC al (888) 466-2219. Los usuarios de TDD deben llamar al (877) 688-9891.
Si las tiene, adjunte copias de cartas u otros documentos sobre el servicio o artículo que denegamos. Esto puede acelerar el proceso de IMR. Envíe copias de los documentos, no los originales. El Centro de Ayuda no puede devolver ningún documento.
Conteste el Formulario de asistente autorizado si alguien lo está ayudando con su IMR. Puede obtener el formulario en http://www.dmhc.ca.gov/FileaComplaint/SubmitanIndependentMedicalReviewComplaintForm.aspx o llame al Centro de Ayuda del DMHC al (888) 466-2219. Los usuarios de TDD deben llamar al (877) 688-9891.
Envíe por correo o fax sus formularios y cualquier documento adjunto a:
Help Center
Department of Managed Health Care
980 Ninth Street, Suite 500
Sacramento, CA 95814-2725
FAX: 916-255-5241
Si califica para una IMR, el DMHC revisará su caso y le enviará una carta en un plazo de 7 días consecutivos en la que le dirá si califica para una IMR. Después de que se reciban su solicitud y documentos de apoyo de su plan, la decisión de la IMR se tomará en un plazo de 30 días consecutivos. Debería recibir la decisión de la IMR en un plazo de 45 días consecutivos después de la presentación de la solicitud completada.
Si su caso es urgente y califica para una IMR, el DMHC lo revisará y le enviará una carta en un plazo de 2 días consecutivos en la que le dirá si califica para una IMR. Después de que se reciban su solicitud y documentos de apoyo de su plan, la decisión de la IMR se tomará en un plazo de 3 días consecutivos. Debería recibir la decisión de la IMR en un plazo de 7 días consecutivos después de la presentación de la solicitud completada.
Si no está satisfecho con el resultado de la IMR, todavía puede pedir una audiencia estatal.
Si el DMHC decide que su caso no es elegible para una IMR, el DMHC revisará su caso mediante su proceso habitual de quejas de consumidores.
2) Audiencia estatal
Puede pedir una audiencia estatal por servicios y artículos cubiertos de Medi-Cal. Si su doctor u otro proveedor pide un servicio o artículo que no aprobaremos, o no seguiremos pagando un servicio o artículo que ya tiene y decimos que no a su apelación de Nivel 1, usted tiene derecho a pedir una audiencia estatal.
En la mayoría de los casos tiene 120 días para pedir una audiencia estatal después de que le envíen por correo el aviso de “Sus derechos de audiencia”.
NOTA: Si pide una audiencia estatal porque le dijimos que un servicio que usted recibe actualmente cambiará o se suspenderá, usted tiene menos días para presentar su solicitud si quiere seguir recibiendo ese servicio mientras espera la audiencia estatal. Lea “¿Continuarán mis beneficios durante las apelaciones de Nivel 2?” en el Capítulo 9 del Manual para Miembros para obtener más información.
Hay dos formas de pedir una audiencia estatal:
Puede completar la “Solicitud de audiencia estatal” en la parte de atrás del aviso de resolución. Debería dar toda la información solicitada, como su nombre completo, domicilio, número de teléfono, el nombre del plan o condado que tomó la resolución en su contra, los programas de asistencia involucrados y una fundamentación detallada de por qué quiere una audiencia. Luego puede presentar su solicitud de una de estas maneras:
Al Departamento de Bienestar del condado a la dirección que aparece en el aviso.
Al Departamento de Servicios Sociales de California:
State Hearings Division
P.O. Box 944243, Mail Station 9-17-37
Sacramento, California 94244-2430
A la División de Audiencias Estatales al número de fax 916-651-5210 o 916-651-2789.
Puede llamar al Departamento de Servicios Sociales de California al (800) 952-5253. Los usuarios de TDD deben llamar al (800) 952-8349. Si decide pedir una audiencia estatal por teléfono, debe saber que las líneas telefónicas están muy ocupadas.
¿Continuarán mis beneficios durante las apelaciones de Nivel 2?
Si su problema trata de un servicio o artículo cubierto por Medicare, sus beneficios para ese servicio o artículo no continuarán durante el proceso de apelación de Nivel 2 con la Entidad de Revisión Independiente.
Si su problema trata de un servicio o artículo cubierto por Medi-Cal y pide una audiencia estatal imparcial, sus beneficios de Medi-Cal para ese servicio o artículo continuarán hasta que se tome una decisión en la audiencia. Debe pedir una audiencia en uno de los siguientes momentos o antes del que sea posterior para que sus beneficios continúen:
en un plazo de 10 días después de la fecha de envío por correo de nuestro aviso dirigido a usted sobre la ratificación de la determinación de beneficios (decisión sobre la apelación de Nivel 1) adversa; o
en la fecha de vigencia prevista de la resolución.
Si cumple este plazo, puede seguir recibiendo el servicio o artículo en disputa hasta que se tome la decisión de la audiencia.
¿Cómo me enteraré de la decisión?
Si su Apelación de Nivel 2 fue una audiencia estatal, el Departamento de Servicios Sociales de California le enviará una carta que explique su decisión.
Si la decisión de la audiencia estatal es “Sí” a una parte o a todo lo que pidió, debe cumplir la decisión. Debemos cumplir las medidas que se describan en un plazo de 30 días consecutivos desde la fecha en la que recibamos una copia de la decisión.
Si la decisión de la audiencia estatal es “No” a una parte o a todo lo que pidió, eso significa que están de acuerdo con la decisión de Nivel 1. Es posible que suspendamos cualquier ayuda pendiente de pago que esté recibiendo.
Si su Apelación de Nivel 2 fue una revisión médica independiente, el Departamento de Administración de Servicios Médicos le enviará una carta que explique la decisión.
Si la decisión de la revisión médica independiente es “Sí” a una parte o a todo lo que pidió, debemos dar el servicio o tratamiento.
Si la decisión de la revisión médica independiente es “No” a una parte o a todo lo que pidió, eso significa que están de acuerdo con la decisión de Nivel 1. Todavía puede obtener una audiencia estatal.
Si su Apelación de Nivel 2 se hizo a una Entidad de Revisión Independiente de Medicare, le enviarán una carta que explique la decisión.
Si la Entidad de Revisión Independiente dice que “Sí” a una parte o a todo lo que pidió, debemos autorizar la cobertura de la atención médica en un plazo de 72 horas o darle el servicio o artículo en un plazo de 14 días consecutivos después de la fecha en que recibamos la decisión de la IRE.
Si la decisión de la Entidad de Revisión Independiente es “No” a una parte o a todo lo que pidió, eso significa que están de acuerdo con la decisión de Nivel 1. Esto se llama “ratificar la decisión”. También se llama “rechazar su apelación”.
Si la decisión es es “No” para una parte o todo lo que pedí, ¿puedo hacer otra apelación?
Si su Apelación de Nivel 2 fue una audiencia estatal, puede pedir una nueva audiencia en un plazo de 30 días después de que usted reciba la decisión. También puede pedir una revisión judicial de una denegación en audiencia estatal mediante la presentación de una petición ante el Tribunal Superior (según el Artículo 1094.5 del Código de Procedimiento Civil) en un plazo de un año después de que usted reciba la decisión.
Si su Apelación de Nivel 2 fue una revisión médica independiente, puede pedir una audiencia estatal.
Si su Apelación de Nivel 2 se hizo a la Entidad de Revisión Independiente de Medicare, puede volver a apelar solamente si el valor en dólares del servicio o artículo que quiere cumple una determinada cantidad mínima. La carta que reciba de la IRE explicará los derechos de apelación adicionales que es posible que usted tenga.
Problemas de pago
No permitimos que nuestros proveedores de la red le facturen a usted los servicios y artículos cubiertos. Esto es así incluso si le pagamos al proveedor menos que lo que el proveedor cobra por un servicio o artículo cubierto. Nunca tendrá la obligación de pagar el saldo de ninguna factura. La única cantidad que se le pedirá que pague es el copago por las categorías de servicios, artículos o medicamentos que requieran un copago. Si recibe una factura que excede su copago por servicios y artículos cubiertos, envíenos la factura a nosotros. Usted no debería pagar la factura. Nos comunicaremos con el proveedor directamente y resolveremos el problema.
¿Cómo le pido al plan que me reembolse la parte de los servicios o artículos médicos que pagué y que le corresponde al plan?
Recuerde que si recibe una factura que excede su copago por servicios y artículos cubiertos, no debería pagar usted la factura. Pero si paga la factura, puede obtener un reembolso si siguió las normas para obtener los servicios y artículos.
Si está pidiendo un reembolso, está pidiendo una decisión de cobertura. Veremos si el servicio o artículo que usted pagó es un servicio o artículo cubierto, y verificaremos si siguió todas las normas para usar su cobertura.
Si el servicio o artículo que usted pagó está cubierto y siguió todas las normas, le enviaremos el pago de nuestra parte del costo del servicio o artículo en un plazo de 60 días consecutivos después de haber recibido su solicitud.
O, si no ha pagado el servicio o artículo todavía, le enviaremos el pago directamente al proveedor. Cuando enviamos el pago, es lo mismo que decir que “Sí” a su solicitud de una decisión de cobertura.
Si el servicio o artículo no está cubierto o usted no siguió todas las normas, le enviaremos una carta en la que le diremos que no pagaremos el servicio o artículo y le explicaremos por qué.
¿Qué pasa si el plan dice que no pagará?
Si no está de acuerdo con nuestra decisión, puede hacer una apelación. Siga el proceso de apelación. Cuando siga estas instrucciones, tenga en cuenta lo siguiente:
Si hace una apelación para reembolso, debemos darle nuestra respuesta en un plazo de 60 días consecutivos después de recibir su apelación.
Si nos está solicitando un reembolso por atención médica que ya recibió y pagó usted mismo, no tiene permitido solicitar una apelación rápida.
Si respondemos “no” a su apelación y el servicio o artículo suele estar cubierto por Medicare, enviaremos automáticamente su caso a la Entidad de Revisión Independiente. Le avisaremos por carta si esto sucede.
Si la IRE revoca nuestra decisión y dice que debemos pagarle, debemos enviarle el pago a usted o al proveedor en un plazo de 30 días consecutivos. Si la respuesta a su apelación es “Sí” en cualquier etapa del proceso de apelación después del Nivel 2, debemos enviarle el pago que pidió a usted o al proveedor en un plazo de 60 días consecutivos.
Si la IRE dice que no a su apelación, significa que está de acuerdo con nuestra decisión de no aprobar su solicitud. (Esto se llama “ratificar la decisión”. También se llama “rechazar su apelación”). La carta que reciba explicará los derechos de apelación adicionales que es posible que usted tenga. Puede volver a apelar solamente si el valor en dólares del servicio o artículo que quiere cumple una determinada cantidad mínima.
Si respondemos “no” a su apelación y el servicio o artículo suele estar cubierto por Medi-Cal, puede presentar una Apelación de Nivel 2 usted mismo (vea arriba).
IEHP DualChoice (HMO D-SNP) es un Plan HMO con un contrato con Medicare. La inscripción en IEHP DualChoice (HMO D-SNP) depende de la renovación del contrato.
La información en esta página está vigente desde el 1 de octubre de 2022.
H8894_DSNP_23_3241532_M
IEHP DualChoice - Problemas con la Parte D
tiene problemas para obtener un medicamento de la Parte D o si quiere un reembolso por un medicamento de la Parte D.
Sus beneficios como miembro de nuestro plan incluyen cobertura para muchos medicamentos recetados. La mayoría de estos medicamentos son “medicamentos de la Parte D”. Hay algunos medicamentos que Medicare Parte D no cubre, pero que Medi-Cal podría cubrir.
¿Puedo pedir una determinación de cobertura o hacer una apelación por medicamentos recetados de la Parte D?
Sí. Estos son algunos ejemplos de determinación de cobertura que puede pedirnos que hagamos sobre sus medicamentos de la Parte D.
Nos solicita que hagamos una excepción como:
Pedirnos que cubramos un medicamento de la Parte D que no está en la lista de medicamentos cubiertos (formulario) del plan.
Pedirnos que no apliquemos una restricción sobre la cobertura del plan para un medicamento (como por ejemplo límites sobre la cantidad de medicamento que puede obtener).
Nos pregunta si un medicamento está cubierto para usted (por ejemplo, cuando su medicamento está en la lista de medicamentos cubiertos del plan, pero exigimos que obtenga nuestra aprobación antes de que lo cubramos para usted).
Nota: Si su farmacia le dice que no se puede surtir su receta, obtendrá un aviso en el que se le explicará cómo comunicarse con nosotros para pedir una determinación de cobertura.
Nos solicita que paguemos un medicamento recetado que ya compró. Esto es pedir una determinación de cobertura sobre un pago.
Si no está de acuerdo con una decisión de cobertura que hemos tomado, puede apelar nuestra decisión.
¿Qué es una excepción?
Una excepción es permiso para obtener cobertura para un medicamento que normalmente no está en nuestra lista de medicamentos cubiertos o para usar el medicamento sin determinadas normas y limitaciones. Si un medicamento no está en nuestra lista de medicamentos cubiertos o no está cubierto en la forma que a usted le gustaría, puede pedirnos que hagamos una “excepción”.
Cuando pida una excepción, su doctor u otro profesional que emite la receta médica tendrá que explicar los motivos médicos de por qué necesita la excepción.
Estos son ejemplos de excepciones que usted o su doctor u otro profesional que emite la receta médica pueden solicitarnos que hagamos:
Cubrir un medicamento de la Parte D que no está en nuestra lista de medicamentos cubiertos (formulario).
Si aceptamos hacer una excepción y cubrir un medicamento que no está en la lista de medicamentos cubiertos, tendrá que pagar los costos compartidos del medicamento.
No puede solicitar una excepción a la cantidad del copago o coseguro que debe pagar por el medicamento.
Eliminar una restricción sobre nuestra cobertura. Hay normas o restricciones adicionales que se aplican a determinados medicamentos en nuestra lista de medicamentos cubiertos.
Las normas o restricciones adicionales sobre cobertura para determinados medicamentos incluyen:
Tener que consumir la versión genérica de un medicamento en lugar del medicamento de marca.
Obtener aprobación del plan antes de que aceptemos cubrir el medicamento para usted. (Esto a veces se llama “autorización previa”).
Tener que probar con un medicamento diferente antes de que aceptemos cubrir el medicamento que está solicitando. (Esto a veces se llama “terapia escalonada”).
Límites de cantidad. En el caso de algunos medicamentos, el plan limita la cantidad del medicamento que puede obtener.
Si aceptamos hacer una excepción y no aplicar una restricción para usted, puede igual solicitar una excepción para la cantidad de copago que debe pagar por el medicamento.
Información importante que debe saber sobre la solicitud de excepciones
Su doctor u otro profesional que emita la receta médica debe darnos una declaración en la que explique los motivos médicos por los que se solicita una excepción. Nuestra decisión sobre la excepción será más rápida si incluye esta información de su doctor u otro profesional que emita la receta médica cuando solicite la excepción.
Normalmente, nuestra lista de medicamentos cubiertos incluye más de un medicamento para tratar una afección en particular. Estas posibilidades diferentes se llaman medicamentos “alternativos”. Si un medicamento alternativo sería tan eficaz como el medicamento que está solicitando, y no causaría más efectos secundarios u otros problemas médicos, normalmente no aprobaremos su solicitud de excepción.
Diremos que sí o no a su solicitud de una excepción.
Si decimos que sí a su solicitud de una excepción, la excepción normalmente durará hasta el final del año en curso. Esto es así siempre y cuando su doctor siga recetándole el medicamento y ese medicamento siga siendo seguro y eficaz para tratar su afección.
Si decimos que no a su solicitud de una excepción, puede pedir una revisión de nuestra decisión mediante una apelación.
Decisión de cobertura
Qué hacer
Pida el tipo de decisión de cobertura que quiere. Llámenos, escríbanos o envíenos por fax para hacer su solicitud. Usted, su representante o su doctor (u otro profesional que emita la receta médica) puede hacer esto.
Puede llamarnos al: (877) 273-IEHP (4347), 8am – 8pm (hora del Pacífico), los 7 días de la semana, incluyendo los feriados. Los usuarios de TTY deben llamar al 1-800-718-4347.
Puede enviarnos un fax al: (909) 890-5877
Puede escribirnos a:
IEHP DualChoice
P.O. Box 1800
Rancho Cucamonga, CA 91729-1800
Usted o su doctor (u otro profesional que emita la receta médica) u otra persona que actúe en su nombre puede pedir una decisión de cobertura. También puede tener un abogado que actúe en su nombre.
No es necesario que autorice por escrito a su doctor u otro profesional que emita la receta médica permiso para que nos pida una determinación de cobertura en su nombre.
Si está solicitando una excepción, presente la “declaración de apoyo”. Su doctor u otro profesional que emita la receta médica debe darnos los motivos médicos por los que se solicita una excepción para medicamento. A esto le llamamos “declaración de apoyo”.
Su doctor u otro profesional que emita la receta médica puede enviarnos la declaración por fax o correo. O su doctor u otro profesional que emita la receta médica puede decirnos por teléfono, y luego enviar una declaración por fax o correo.
Solicitud de determinación de cobertura de medicamentos recetados de Medicare (PDF)
Estos formularios también están disponibles en el sitio web de los CMS:
Formulario de solicitud de determinación de medicamentos recetados de Medicare (para afiliados y proveedores)
Haciendo clic en este enlace, saldrá del sitio web de IEHP DualChoice.
Plazos para una “decisión de cobertura estándar” sobre un medicamento que todavía no ha recibido
Si usamos los plazos estándar, debemos darle nuestra respuesta en un plazo de 72 horas después de que recibamos su solicitud o, si está solicitando una excepción, después de que recibamos la declaración de apoyo de su doctor u otro profesional que emita la receta médica. Le daremos nuestra decisión lo antes posible si su salud lo requiere.
Si no cumplimos este plazo, enviaremos su solicitud al Nivel 2 del proceso de apelación. En el Nivel 2, una Entidad de Revisión Independiente revisará la decisión.
Si nuestra respuesta es “Sí” a una parte o a todo lo que pidió, debemos aprobar o darle la cobertura en un plazo de 72 horas después de haber recibido su solicitud o, si está solicitando una excepción, la declaración de apoyo de su doctor u otro profesional que emita la receta médica.
Si nuestra respuesta es “No” a una parte o la totalidad de lo que pidió, le enviaremos una carta que explique por qué dijimos que no. La carta también explicará cómo puede apelar nuestra decisión.
Plazos para una “decisión de cobertura estándar” sobre el pago de un medicamento que usted ya compró
Debemos darle nuestra respuesta en un plazo de 14 días consecutivos después de recibir su solicitud.
Si no cumplimos este plazo, enviaremos su solicitud al Nivel 2 del proceso de apelación. En el Nivel 2, una Entidad de Revisión Independiente revisará la decisión.
Si nuestra respuesta es “Sí” a una parte o a todo lo que pidió, le haremos el pago en un plazo de 14 días consecutivos.
Si nuestra respuesta es “No” a una parte o a todo lo que pidió, le enviaremos una carta que explique por qué dijimos que no. Esta declaración también explicará cómo puede apelar nuestra decisión.
Si su salud lo requiere, pídanos que le demos una “decisión de cobertura rápida”.
Usaremos los “plazos estándar” a menos que hayamos acordado usar los “plazos rápidos”.
Una decisión de cobertura estándar significa que le daremos una respuesta en un plazo de 72 horas después de recibir la declaración de su doctor.
Una decisión de cobertura rápida significa que le daremos una respuesta en un plazo de 24 horas después de recibir la declaración de su doctor.
Puede obtener una decisión de cobertura rápida solamente si está pidiendo un medicamento que todavía no ha recibido. (No puede obtener una decisión de cobertura rápida si nos está pidiendo un reembolso por un medicamento que usted ya compró).
Puede obtener una decisión de cobertura rápida solo si el uso de los plazos estándar causaría un daño grave a su salud o si su capacidad para funcionar se vería afectada.
Si su doctor u otro profesional que emite la receta médica nos dice que requiere una “decisión de cobertura rápida” por su salud, aceptaremos automáticamente darle una decisión de cobertura rápida, y la carta le dirá eso.
Si usted pide una decisión de cobertura rápida por su cuenta (sin el apoyo de su doctor u otro profesional que emita la receta médica), decidiremos si obtendrá una decisión de cobertura rápida o no.
Si decidimos que su afección médica no cumple los requisitos para una decisión de cobertura rápida, usaremos los plazos estándar.
Le enviaremos una carta en la que le diremos eso. La carta lo informará de cómo hacer una queja sobre nuestra decisión de darle una decisión estándar.
Puede presentar una “queja rápida” y recibir una respuesta a su queja en un plazo de 24 horas.
Plazos para una “decisión de cobertura rápida”
Si estamos usando los plazos rápidos, debemos darle nuestra respuesta en un plazo de 24 horas. Esto significa en un plazo de 24 horas después de que recibamos su solicitud. O, si está solicitando una excepción, 24 horas después de que recibamos la declaración de su doctor u otro profesional que emita la receta médica de apoyo a su solicitud. Le daremos nuestra decisión lo antes posible si su salud requiere que lo hagamos.
Si no cumplimos este plazo, enviaremos su solicitud al Nivel 2 del proceso de apelación. En el Nivel 2, una organización independiente externa revisará su solicitud y nuestra decisión.
Si nuestra respuesta es “Sí” a una parte o a todo lo que pidió, debemos darle la cobertura en un plazo de 24 horas después de haber recibido su solicitud o la declaración de su doctor u otro profesional que emita la receta médica de apoyo a su solicitud.
Si nuestra respuesta es “No” a una parte o la totalidad de lo que pidió, le enviaremos una carta que explique por qué dijimos que no. La carta también explicará cómo puede apelar nuestra decisión.
Apelación de Nivel 1 para medicamentos de la Parte D
Para comenzar su apelación, usted, su doctor u otro profesional que emita la receta médica o su representante deben comunicarse con nosotros.
Si está solicitando una apelación estándar, puede hacer su apelación enviando una solicitud por escrito. También puede pedir una apelación llamando a Servicios para Miembros de IEHP DualChoice al 1-877-273-IEHP (4347), 8am – 8pm (hora del Pacífico), los 7 días de la semana, incluyendo feriados. Los usuarios de TTY/TTD deben llamar al 1-800-718-4347.
Si quiere una apelación rápida, puede presentarla por escrito o puede llamarnos.
Haga su solicitud de apelación en un plazo de 60 días consecutivos después de la fecha del aviso que le enviamos para informarlo de nuestra decisión. Si no cumple este plazo por un buen motivo, es posible que le demos más tiempo para hacer la apelación. Por ejemplo, algunos buenos motivos por los que podría perderse el plazo serían tener una enfermedad grave que le impida comunicarse con nosotros o que le hayamos dado información incorrecta o incompleta sobre el plazo para pedir una apelación.
Puede pedir una copia de la información de su apelación y agregar más información.
Tiene derecho a pedirnos una copia de la información sobre su apelación.
Si quiere, usted y su doctor u otro profesional que emita la receta médica pueden darnos información adicional para apoyar su apelación.
Puede usar el siguiente formulario para presentar una apelación:
Formulario de determinación de cobertura (PDF)
¿Puede otra persona hacer la apelación por mí?
Sí. Su doctor u otro proveedor pueden hacer la apelación por usted. También, otra persona además de su doctor u otro proveedor pueden hacer la apelación por usted, pero primero debe contestar un Formulario de designación de representante. El formulario autoriza a la otra persona para que actúe en su nombre.
Si la apelación proviene de alguien que no es usted o su doctor u otro proveedor, debemos recibir el formulario de designación de representante completado para poder revisar la apelación.
Plazos para una “apelación estándar”
Si usamos los plazos estándar, debemos darle nuestra respuesta en un plazo de 7 días consecutivos después de recibir su apelación, o lo antes posible si lo requiere su salud. Si cree que su salud lo requiere, debería solicitar una “apelación rápida”. Si nos está solicitando un reembolso por un medicamento que usted ya compró, debemos darle nuestra respuesta en un plazo de 14 días consecutivos después de recibir su apelación.
Si no le damos una decisión en un plazo de 7 días consecutivos, o 14 días si nos solicitó un reembolso por un medicamento que usted ya compró, enviaremos su solicitud al Nivel 2 del proceso de apelación. En el Nivel 2, una Entidad de Revisión Independiente revisará nuestra decisión.
Si su salud lo requiere, solicite una “apelación rápida”.
Si está apelando una decisión que tomó nuestro plan sobre un medicamento que todavía no ha recibido, usted y su doctor u otro profesional que emita la receta médica tendrán que decidir si necesita una “apelación rápida”.
Los requisitos para obtener una “apelación rápida” son los mismos que para obtener una “decisión de cobertura rápida”.
Nuestro plan revisará su apelación y le dará nuestra decisión.
Revisamos nuevamente con atención toda la información sobre su solicitud de cobertura. Verificamos si seguimos todas las normas cuando respondimos que no a su solicitud. Es posible que nos comuniquemos con usted o su doctor u otro profesional que emita la receta médica para obtener más información.
Plazos para una “apelación rápida”
Si estamos usando los plazos rápidos, le daremos nuestra respuesta en un plazo de 72 horas después de recibir su apelación, o lo antes posible si lo requiere por su salud.
Si no le damos una respuesta en un plazo de 72 horas, enviaremos su solicitud al Nivel 2
del proceso de apelación. En el Nivel 2, una Entidad de Revisión Independiente revisará su apelación.
Si nuestra respuesta es “Sí” a una parte o a todo lo que pidió, debemos dar la cobertura en un plazo de 72 horas después de haber recibido su apelación.
Si nuestra respuesta es “No” a una parte o a todo lo que pidió, le enviaremos una carta que explique por qué dijimos que no.
Apelación de Nivel 2 para medicamentos de la Parte D
Si decimos que no a su apelación, usted elige si acepta esta decisión o continúa haciendo otra apelación. Si decide hacer una Apelación de Nivel 2, la Entidad de Revisión Independiente (IRE) revisará nuestra decisión.
Si quiere que la organización de revisión independiente revise su caso, su solicitud de apelación debe hacerse por escrito.
Solicítela en el plazo de los 60 días después de la decisión que está apelando. Si no cumple el plazo por un buen motivo, es posible que todavía pueda apelar.
Usted, su doctor u otro profesional que emita la receta médica o su representante pueden pedir la Apelación de Nivel 2.
Cuando haga una apelación a la Entidad de Revisión Independiente, les enviaremos el expediente de su caso. Tiene derecho a pedirnos una copia del expediente de su caso. Tiene derecho a darle a la Entidad de Revisión Independiente otra información para apoyar su apelación. La Entidad de Revisión Independiente es una organización independiente que contrata Medicare. No tiene ninguna conexión con este plan y no es una agencia gubernamental. Los revisores de la Entidad de Revisión Independiente analizarán con atención toda la información relacionada con su apelación. La organización le enviará una carta en la que se explicará su decisión.
Si ratificamos la denegación después de la redeterminación, usted tiene derecho a pedir una reconsideración. Vea el formulario abajo:
Formulario de reconsideración (PDF)
Plazos para una “apelación rápida” en el Nivel 2
Si su salud lo requiere, solicítele a la Entidad de Revisión Independiente una “apelación rápida”.
Si la organización revisora acepta darle una “apelación rápida”, debe darle una respuesta a su Apelación de Nivel 2 en un plazo de 72 horas después de recibir su solicitud de apelación.
Si la Entidad de Revisión Independiente dice que sí a una parte o a todo lo que pidió, debemos autorizar o dar la cobertura del medicamento en un plazo de 24 horas después de que recibamos la decisión.
Plazos para “apelación estándar” en el Nivel 2
Si tiene una apelación estándar en el Nivel 2, la Entidad de Revisión Independiente debe darle una respuesta a su Apelación de Nivel 2 en un plazo de 7 días consecutivos después de que reciba su apelación.
Si la Entidad de Revisión Independiente dice que sí a una parte o a todo lo que pidió, debemos autorizar o dar la cobertura del medicamento en un plazo de 72 horas después de que recibamos la decisión.
Si la Entidad de Revisión Independiente aprueba una solicitud de reembolso por un medicamento que usted ya compró, le enviaremos el pago a usted en un plazo de 30 días consecutivos después de recibir la decisión.
¿Qué pasa si la Entidad de Revisión Independiente dice que no a su Apelación de Nivel 2?
Decir que no significa que la Entidad de Revisión Independiente está de acuerdo con nuestra decisión de no aprobar su solicitud. Esto se llama “ratificar la decisión”. También se llama “rechazar su apelación”.
Si el valor en dólares de la cobertura del medicamento que quiere cumple una determinada cantidad mínima, puede hacer otra apelación en el Nivel 3. La carta que reciba de la Entidad de Revisión Independiente le dirá la cantidad en dólares necesaria para continuar con el proceso de apelación. Un juez de derecho administrativo se ocupará de la Apelación de Nivel 3.
Para obtener más información, consulte el Capítulo 9 del Manual para Miembros de IEHP DualChoice.
IEHP DualChoice (HMO D-SNP) es un Plan HMO con un contrato con Medicare. La inscripción en IEHP DualChoice (HMO D-SNP) depende de la renovación del contrato.
La información en esta página está vigente desde el 1 de octubre de 2022.
H8894_DSNP_23_3241532_M
MediCal - Pharmacy Communications
or later to view the PDF files. You can download a free copy by clicking here. By clicking on this link, you will be leaving the IEHP website.
TITLE
DATE
RECIPIENTS
March 2023
DualChoice Medicare Billing for Non-FDA Approved Medications
03/21
All IEHP Pharmacy Providers
Claim Processing during State of Emergency due to Snowstorm
03/03
All IEHP Pharmacy Providers
February 2023
Transition to 30-day Coverage Determination Backdating
02/02
All LTC & SNF Providers
January 2023
IEHP DualChoice (HMO D-SNP): Over-the-Counter Drugs
01/09-01/30
All IEHP Pharmacy Providers
IEHP DualChoice (HMO D-SNP): Medicare Part B Coinsurance Billing
01/05-01/13
All IEHP Pharmacy Providers
IEHP DualChoice (HMO D-SNP): PBM Update and Medicare Part B Coinsurance
01/02-01/20
All IEHP Pharmacy Providers
IEHP DualChoice (HMO D-SNP) Members - Medication Overrides
01/02
All IEHP Pharmacy Providers
December 2022
Cal MediConnect (CMC) to Medi-Cal Rx/HMO D-SNP Transition
12/22
All IEHP Pharmacy Providers
Claims Rejected in Error
12/19
All IEHP Pharmacy Providers
PBM Change & Prior Authorization Submission Method - for DualChoice (HMO D-SNP) Members (Effective January 1, 2023)
12/13-12/29
All IEHP Pharmacy Providers
Pharmacy Recalls, Withdrawals & Safety Alerts - November 2022
12/07
All IEHP Pharmacy Providers
CoverMyMeds - Prior Authorization Submission Method for DualChoice Members (Effective January 1, 2023)
12/01-12/12
All IEHP Pharmacy Providers
November 2022
Recalls, Withdrawals & Safety Alerts - October 2022
11/14
All IEHP Pharmacy Providers
Recalls, Withdrawals & Safety Alerts - September 2022
11/02
All IEHP Pharmacy Providers
COVID-19: Test to Treat Monoclonal Antibodies
11/01
All IEHP Pharmacy Providers
October 2022
Cal MediConnect to Medi-Cal Rx Transition (D-SNP)
10/28
All IEHP Pharmacy Providers
September 2022
Recalls, Withdrawals & Safety Alerts
09/08
All IEHP Pharmacy Providers
August 2022
2022-2023 Flu Vaccination for IEHP Members
08/31
All IEHP Pharmacy Providers
Reminder: Medi-Cal Rx Gradual Reinstatement of PAs - Phase 1
08/31
All IEHP Pharmacy Providers
30-Day Countdown: Reinstatement of PA Requirements for 11 Drug Classes
08/18
All IEHP Pharmacy Providers
30-Day Countdown: Reinstatement of PA Requirements for 11 Drug Classes
08/17
All IEHP Pharmacy Providers
Recalls, Withdrawals & Safety Alerts
08/10
All IEHP Pharmacy Providers
July 2022
Academic Detailing Services Now Offered
07/15
All IEHP Pharmacy Providers
DHCS Medi-Cal Rx Update: Postponement of Implementation of NCPDP Reject Code 80
07/13
All IEHP Pharmacy Providers
Recalls, Withdrawals & Safety Alerts
07/07
All IEHP Pharmacy Providers
June 2022
New DHCS DUR Board Educational Article
06/22
All IEHP Pharmacy Providers
MTM Medicare Pharmacy Mailing Campaign
06/08
All IEHP Pharmacy Providers
Recalls, Withdrawals & Safety Alerts
06/05
All IEHP Pharmacy Providers
Academic Detailing Services Now Offered
06/04
All IEHP Pharmacy Providers
Medi-Cal Rx Transition: Blood Pressure Monitors and Cuffs
06/03
All IEHP Pharmacy Providers
Important Notice: COVID-19 Oral Antivirals Billing
06/01
All IEHP Pharmacy Providers
May 2022
Recalls, Withdrawals & Safety Alerts
05/05
All IEHP Pharmacy Providers
April 2022
Rejected Claims Due To Prescriber Error Codes
04/06
All IEHP Pharmacy Providers
Recalls, Withdrawals & Safety Alerts
04/05
All IEHP Pharmacy Providers
MTM COVID-19: Test to Treat
04/04
All IEHP Pharmacy Providers
March 2022
MTM Medicare Pharmacy Mailing Campaign
03/29
All IEHP Pharmacy Providers
New DHCS DUR Board Educational Article
03/16
All IEHP Pharmacy Providers
Medi-Cal Rx Transition: How To Assist IEHP Members
03/28-03/31
All IEHP Pharmacy Providers
Medi-Cal Rx Transition: How To Assist IEHP Members
03/21-03/25
All IEHP Pharmacy Providers
Medi-Cal Rx Transition: How To Assist IEHP Members
03/14-03/18
All IEHP Pharmacy Providers
Medi-Cal Rx Transition: How To Assist IEHP Members
03/07-03/11
All IEHP Pharmacy Providers
Recalls, Withdrawals & Safety Alerts
03/07
All IEHP Pharmacy Providers
IEHP Contracted DME Pharmacies: CGM, BP Monitor, Nebulizer
03/02
All IEHP Pharmacy Providers
February 2022
Medi-Cal Rx Transition: How To Assist IEHP Members
02/28-03/04
All IEHP Pharmacy Providers
Medi-Cal Rx Transition: How To Assist IEHP Members
02/22-02/25
All IEHP Pharmacy Providers
Medi-Cal Rx Transition: How To Assist IEHP Members
02/14-02/18
All IEHP Pharmacy Providers
Medi-Cal Rx Transition: How To Assist IEHP Members
02/10-02/11
All IEHP Pharmacy Providers
Pharmacy Empowerment Program
02/08
All IEHP Pharmacy Providers
Recalls, Withdrawals & Safety Alerts
02/07
All IEHP Pharmacy Providers
New DHCS DUR Board Educational Article
02/02
All IEHP Pharmacy Providers
January 2022
Free OTC COVID-19 Antigen Test Kits Available
01/31
All IEHP Pharmacy Providers
Medi-Cal Rx Transition Implementation
01/17-01/21
All IEHP Pharmacy Providers
Medi-Cal Rx Transition Implementation
01/10-01/14
All IEHP Pharmacy Providers
Medi-Cal Rx Transition Implementation
01/07
All IEHP Pharmacy Providers
Recalls, Withdrawals & Safety Alerts
01/05
All IEHP Pharmacy Providers
MediCal - Utilization Management Criteria
e. IEHP has created UM Subcommittee Approved Authorization Guidelines to serve as one of the sets of criteria for medical necessity decisions. Our goal in creating this page is to provide you with easily accessible electronic versions of IEHP’s UM guidelines. IEHP utilizes a variety of sources in developing our UM guidelines which include:
Medicare and Medi-Cal’s coverage policy statements
Evidence in the peer-reviewed published medical literature
Technology assessments and structured evidence reviews
Evidence-based consensus statements
Expert opinions of healthcare Providers
Evidence-based guidelines from nationally recognized professional healthcare organizations and public health agencies.
IEHP is also licensed to use MCG Guidelines, Apollo Medical Review Criteria, and InterQual to guide in utilization management decisions.
Since medical technology is constantly evolving, our clinical guidelines are subject to change without prior notification. Additional UM Subcommittee Guidelines may be developed as needed or may be withdrawn from use.
Please note that benefits may vary based on Member’s line of business; therefore, certain services discussed in the UM Subcommittee Guidelines may not be a covered benefit.
Table of Contents (PDF)
Providers may obtain information about criteria, either in general or relating to specific UM decisions, from IEHP upon request by contacting the IEHP UM Department. Please contact the IEHP Provider Relations Team at (909) 890-2054 to be connected to the UM Department.
Behavioral Health
Behavioral Health Treatment (BHT) Criteria (PDF)
Criteria for Multidisciplinary Diagnostic Treatment (PDF)
Community Supports Services
Community Transition Services Nursing Facility Transition to a Home (PDF)
Nursing Facility Transition-Diversion to Assisted Living (PDF)
Housing Deposits (PDF)
Housing Transition Navigation Services (PDF)
Housing Tenancy and Sustaining Services (PDF)
Asthma Remediation (PDF)
Environmental Accessibility Adaptations (Home Modifications) (PDF)
Medically Tailored Meals (PDF)
Sobering Centers (PDF)
Recuperative Care (PDF)
Short-Term Post-Hospitalization Housing (PDF)
Diagnostic Testing
Elastography (PDF)
Inflammatory Bowel Disease Serology (PDF)
Vestibular Autorotation Test (PDF)
Gynecology and Obstetrics
Fetal Non-Stress Testing (PDF)
Neurology
Bone Marrow Transplant in Treatment of Multiple Sclerosis (PDF)
Pain Management
Pain Management - Centers of Excellence (COE) (PDF)
Referrals to Pain Management Specialist (PDF)
Pharmacy
Biosimilar Products (PDF)
CAR-T Therapy (PDF)
Surgical Procedures
Adolescent Bariatric Consultation and Surgery (PDF)
Natural Orifice Transluminal Endoscopic Surgery (PDF)
Transgender Services (PDF)
Other
Allocation of Limited Critical Care Resources During a Public Health Emergency (PDF)
Complementary and Alternative Medicine or Holistic Therapies (PDF)
Congregate Living Health Facilities (PDF)
Criteria for Custodial Care: Medi-Cal (PDF)
Enhanced Care Management (PDF)
Hair Removal Guideline (PDF)
My Path (A Palliative Care Approach) (PDF)
Tertiary Care Center Referral Requests (PDF)
Transitional Care Medicine (PDF)
Transportation Criteria (PDF)
You will need Adobe Acrobat Reader 6.0 or later to view the PDF files. You can download a free copy by clicking here.
MediCal - Non-Contracted Providers
s for Contracted and Non-Contracted Providers
Emergency and Post-Stabilization Care for IEHP Members
IEHP DualChoice (HMO D-SNP) Model of Care Training for Non-Contracted Providers
Provider Dispute Resolution Process for Contracted and Non-Contracted Providers
Definition of a Provider Dispute
A provider dispute is a written notice from the provider to Inland Empire Health Plan (IEHP) that:
Challenges, appeals, or appeals, or requests reconsideration of a claim (including a bundled group of similar claims) that has been denied, adjusted, or contested
Challenges a request for reimbursement for an overpayment of a claim
Seeks resolution of a billing determination or other contractual dispute
What is not Considered to be a Provider Dispute
Claims denied for missing or additional documentation requirements such as consent forms, invoices, Explanation of Benefits from primary carrier, or itemized bills are not considered Provider Disputes
Corrected Claims
Pre-Service Authorization Denials
Provider Dispute Time Frame
IEHP accepts disputes from providers if they are submitted within 365 days of receipt of IEHPs decision (for example, IEHPs Remittance Advice (RA) indicating a claim was denied or adjusted).
Submission of Provider Disputes
When submitting a provider dispute, a provider should use a Provider Dispute Resolution Request form. If the dispute is for multiple, substantially similar claims, complete the spreadsheet on page 2 of the Provider Dispute Resolution Request Form
All Provider Disputes and supporting information must be submitted to:
IEHP Claims Appeal Resolution Unit
PO BOX 4319
Rancho Cucamonga, CA 91729-4349
Acknowledgement of Provider Dispute
IEHP acknowledges receipt of each provider dispute, regardless of whether the dispute is complete, within 15 business days of receipt.
Resolution Timeframe
IEHP resolves each provider dispute within 45 business days following receipt of the dispute, and provides the provider with a written determination stating the reasons for determination.
PDR Determination Resulting in Additional Payment
If IEHP determines to pay additional monies based on information originally provided and/or available at the time the claim was first presented to IEHP for adjudication, or a result of a processing error IEHP will automatically include the appropriate interest amount if payment is not issued within required regulatory timeframes.
Non-Contracted Provider Disputes Resolution Process for IEHP DualChoice (HMO D-SNP)
A non-contracted provider, on his or her own behalf, is permitted to file a standard appeal for a denied claim only if the non-contracted provider completes a waiver of liability statement, which provides that the non-contracted provider will not bill IEHP DualChoice (HMO D-SNP) Plan Members.
Who to Call with Questions on IEHPs PDR Process
Contracted providers may visit our online secure provider portal at www.iehp.org for more information. Providers may also call the IEHP Provider Call Center at (909) 890-2054 or (866) 223-4347 Monday-Friday, 8:00 am to 5pm PST.
(Back to Non-Contracted Providers Menu)
Emergency and Post-Stabilization Care for IEHP Members
Triage and Advice Systems
IEHP provides Members triage, screening, and advice services by telephone 24 hours a day, 7 days a week through its Nurse Advice Line (NAL). By calling the NAL, Members receive assistance with access to urgent or emergency services from an on-call physician, or licensed triage personnel. IEHP Members can reach this 24/7 Nurse Advice Line at (888)-244-IEHP (4347) or 711 (TTY).
Post-Stabilization Care
IEHP requires contracted and non-contracted hospitals to obtain prior authorization for post-stabilization care for Members (patients). IEHP requests the patient’s diagnosis as indicated by the treating physician or surgeon and any other information reasonably necessary for the Plan to decide on whether to authorize post-stabilization care or to assume management of the patient’s care by prompt transfer to another facility. The hospital should request prior authorization from IEHP’s Utilization Management (UM) Department by:
Phone at (866) 649-6327; or
Fax at (909) 477-8553 to send clinical notes for medical necessity review.
IEHP makes every effort to respond to requests for necessary post-stabilization care within thirty (30) minutes of receipt. The services are considered approved if IEHP does not respond within this timeframe. All subsequent hospital day are subject to review for medical necessity.
IEHP will inform the provider of the Plan’s decision and will coordinate the transfer of the Member if IEHP denies the request for authorization of post-stabilization care and elects to transfer the Member to another health care provider.
Non-Emergency Services
If a Member presents at the emergency department for non-emergency services, please refer the Member to their IEHP Member Handbook, section 3 (How to Get Care), which outlines the process for obtaining a referral.
Claims Reimbursement
Complete facility claims for authorized health care services must be sent to:
Inland Empire Health Plan
Attn: Claims Department – IEHP Direct
PO BOX 4349
Rancho Cucamonga, CA 91729-4349
Complete professional claims for authorized health care services must be sent to:
For IEHP-Direct Members, please send to address above.
For IEHP Members assigned to an IPA, please click for here for more information on how to send to the appropriate IPA.
Billing IEHP Members
Providers under the Medi-Cal program must not submit claims to, demand or otherwise collect reimbursement from a Medi-Cal beneficiary, or from other persons on behalf of the beneficiary, for any service included in the Medi-Cal program’s scope of benefits in addition to a claim submitted to the Medi-Cal program for that service.
IEHP DualChoice (HMO D-SNP) Model of Care Training for Non-Contracted Providers
The Centers for Medicare & Medicaid Services (CMS), the Department of Health Care Services (DHCS), and National Committee for Quality Assurance (NCQA) requirement that out-of-network providers routinely seen by IEHP DualChoice (HMO D-SNP) Members, receive training on IEHPs Model of Care for our D-SNP Members:
IEHP DualChoice (HMO D-SNP) Model of Care Training (PDF)
IEHP DualChoice (HMO D-SNP) Model of Care Training (HTML)
*We recommend opening file in: Mozilla Firefox, MS Edge, Chrome or MS Internet Explorer
2023 IEHP DualChoice (HMO D-SNP) Model of Care Non-Contracted Provider AOR (PDF)
Report an Issue
To report any issues with this system or process or for any questions, please send an email to DGHospitalRelationsServiceTeam@iehp.org
(Back to Non-Contracted Providers Menu)
You will need Adobe Acrobat Reader 6.0 or later to view the PDF files. You can download a free copy by clicking here.
Plan Updates - Correspondence
here.
TITLE
DATE
RECIPIENTS
March 2023
I-MEDIC and CMS Alerts - Provider Potentially Inappropriate Billing
03/24
All Medicare IPAs
REMINDER – Action Required by March 31st - Blood Lead Survey
03/23
All Pediatricians, Family Practice & Community Clinics
REMINDER - IEHP Contracts with Call the Car for Transportation
03/23
All Hospital Administrators, SNFs & Dialysis Center
REVISED – UM Authorization Guidelines
03/22
All IPA Administrators, Medical Directors & BH Providers
Reminder Coordination of Care Reports and Rosters
03/21
All IPAs
2023 IEHP Direct Stars Incentive Program Guide Release
03/17
All Direct DualChoice PCPs
PHA - Increased Enteric Disease Activity - Shigella
03/17
All PCPs
Manifest MedEx Seminar - Achieve IEHP's MX Connectivity Quality Process Measure
03/17
All Medi-Cal PCPs
Phase III – Lift 1 - Medi-Cal Rx Transition Policy Change
03/16
All Medi-Cal PCPs & Specialists
RESPONSE REQUIRED – Provider Newsletter and Communication Survey
03/15
All PCPs, Specialists, Vision, BH & BHT Providers
REMINDER - 2023 Global Quality P4P Program - CAIR2 Participation Requirement
03/15
All Medi-Cal PCPs
Comprehensive Practice Optimization Workshop
03/15
All Riverside County PCPs
Medical Assistants: Enhancing Patient Safety & Reducing Liability Risks
03/15
All Riverside County PCPs
IEHP Coordination of Benefits Agreement (COBA) Implementation – Update
03/13
All PCPs, Specialists, Ancillary, & Hospitals
ACTION REQUIRED - Blood Lead Survey
03/13
All Pediatricians, Family Practice & Community Clinics
Opioid Attestation for Coverage Determinations and Removal of X-Waiver
03/10
All DualChoice Providers
Social Determinants of Health - Community Supports Services Referral Process
03/10
All PCPs, Behavioral Health Providers & IPAs
Complex Case Management (CCM) Program – Severe Chronic Conditions
03/08
All Medi-Cal IPAs, PCPs, Specialists, & Behavioral Health Providers
UPDATE - IEHP Coordination of Benefits Agreement (COBA) Implementation
03/07
All FQHCs, IHCs, & RHCs
REMINDER - Clean Claim Tool Guide Available
03/07
All Skilled Nursing Facilities
GQ P4P PCP – 2023 Program Guide Update - Social Determinates of Health Measure
03/03
All Medi-Cal PCPs
GQ P4P IPA – 2023 Program Guide Update - Social Determinates of Health Measure
03/03
All Medi-Cal IPAs
Encouraging Sexual History Taking for Patient Care and Partner Services
03/03
All PCPs
Encounter Data Submission Enhancements – Live Now!
03/02
All Direct PCPs
IEHP Global Quality P4P Manifest MedEx (MX) FAQs
03/02
All Medi-Cal PCPs & IPAs
Riverside County Medical Association - Physician Burnout Webinar
03/02
All Riverside and San Bernardino County PCPs
Riverside County Medical Association's 19th Annual Cruisin' Thru CME
03/02
All Riverside County PCPs
February 2023
CMS Alert - Fraudulent Activities and Monitoring Recommendations
02/28
All Medicare IPAs
Update to D-SNP Letter Template
02/24
All Medicare IPAs
Alternate Contact Information for Members Now Available!
02/23
All PCPs
Alzheimer's and Dementia Seminar (ECHO) - Beginning March 29th
02/23
All PCPs
Month-End IEHP Outbound 834 File Update
02/23
834 Trading Partners
RESPONSE REQUESTED – Provider Newsletter and Communication Survey
02/21
All PCPs, Specialists, Vision, BH and BHT Providers
UPDATE - Referral Timeline Standards for IEHP DualChoice (HMO D-SNP) Members
02/21
All Medicare IPAs
Skinny Gene Project - Diabetes Prevention Program (DPP)
02/21
All PCPs
Protocols for Emergency and Post-Stabilization Care for IEHP Members
02/17
All Hospitals
REMINDER - 2023 Global Quality P4P Program - CAIR2 Participation Requirement- PCPs
02/16
All Medi-Cal PCPs
Last Phase - Medi-Cal Rx Reinstatement of PAs for 46 Drug Classes, Including Medical Supplies - Eff. February 24th
02/14
All Medi-Cal PCPs & Specialists
Presidents' Day Holiday
02/13
All IEHP Providers & IPAs
RESPONSE REQUIRED – Provider Newsletter and Communication Survey
02/13
All PCPs, Specialists, Vision, BH and BHT Providers
New Provider Portal Alert - Inpatient Discharges
02/09
All PCPs
Quality Bonus Services RA’s Now Available!
02/09
All Medi-Cal PCPs
Ask DHCS – Open Office Hours for EVV Home Health Care Services – February 17, 2023
02/03
All EVV Impacted Providers & Individual Nurse Practitioners
UPDATE – Initial Health Appointment and Retirement of IHEBA/SHA
02/02
All Medi-Cal PCPs & IPAs
Transition to 30-day Coverage Determination Backdating
02/02
All LTC & SNF Providers
Redlands Community Hospital – Behavioral Health Unit Closed
02/01
All PCPs & BH Providers
UPDATE - Independent Medical Review Form
02/01
All Medicare IPAs
January 2023
KidsVaxGrant 3.0 Deadline to Apply is February 17, 2023
01/31
All Pediatricians and Family Practice PCPs
Effective February 1, 2023 - Call The Car Will Replace American Logistics Company (ACL) for ALL Member Transportation
01/31
All PCPs, Specialists, BH & IPAs
Provider Manual Acknowledgement of Receipt (AOR) Winners
01/27
All Providers
Crisis Recovery Resource Guide and Toolkit Available
01/27
All Community Support Services
REMINDER - BHT Providers Must Submit Exit Reports and Exit Letters!
01/27
All BHT (QASP) Providers
D-SNP Model of Care Incentive Program - 2023 Program Guide Release
01/26
All Medicare IPAs
Help Protect Members - Flu Vaccine Reminder
01/25
All PCPs
2023 Global Quality P4P PCP Kick Off Meeting
01/25
All Medi-Cal PCPs
2023 Global Quality P4P IPA Kick Off Meeting
01/25
All IPAs
An ECHO Learning Opportunity - Alzheimer's And Dementia Care - Weekly Sessions Begin Feb 16th
01/24
All PCPs
REMINDER - 2023 Global Quality P4P Program - CAIR2 Participation Requirement- PCPs
01/23
All Medi-Cal PCPs
REMINDER - 2023 Global Quality P4P Program - CAIR2 Participation Requirement- IPAs
01/23
All Medi-Cal IPAs
Response Requested by Thursday, January 26! - CBAS Emergency Remote Services (ERS)
01/23
All CBAS Providers
Global Quality P4P PCP Program - 2023 Program Guide Release
01/19
All Medi-Cal PCPs
UPDATE! Medi-Cal Letter Templates
01/17
All Medi-Cal IPAs
Emergency Resource Guide and Services – Flooding Services Available!
01/17
All Community Support Services Providers
Medicare P4P IEHP Direct – Blood Pressure Control Billing Guidance
01/13
All DualChoice PCPs
NEW! Regulatory Submission Response Files – MAO-004 XWalk
01/13
All Medicare IPAs
ALERT! 837 SBR04 Encounter Data Requirement Changes
01/13
All Medicare IPAs
IEHP DualChoice (D-SNP) Model of Care Training Requirement
01/12
All DualChoice Hospitals
IEHP DualChoice (D-SNP) Model of Care Training Requirement
01/10
All Medicare IPAs
IEHP DualChoice (D-SNP) Model of Care Training Requirement
01/10
All DualChoice Providers
IEHP Outbound 834 File Update
01/10
All 834 Trading Partners
IEHP HOLIDAY - Martin Luther King Jr. Day
01/09
All IEHP Providers
CORRECTION to Changes to Quarterly Workplan Requirements
01/05
All Medicare IPAs
LAST CHANCE to Win a $50 Gift Card - Submit 2023 Provider Policy and Provider Manual Acknowledgement of Receipt (AOR)
01/04
All IEHP Providers
2023 Population Health Management Academy
01/04
All Riverside County PCPs
CORRECTION - 2022 GQ P4P PCP - Quality Bonus Services Code Update
01/03
All Medi-Cal PCPs
December 2022
Outbound Eligibility File Delay on January 1, 2023
12/29
All IPAs and Ancillary Providers
REMINDER - CoverMyMeds - Prior Authorization Submission Method for Dual Choice Members– Effective January 1, 2023
12/29
All Dual Choice PCPs & Specialists
REMINDER - Pharmacy Benefits Manager (PBM) Change for DualChoice (HMO D-SNP) - Member Outreach in Process
12/29
All Dual Choice PCPS and Medicare IPAs
Access Standards – Appointment Availability - BH Providers
12/28
All Behavioral Health Providers
Mandatory Managed Care Enrollment (MMCE) Phase II - January 1, 2023
12/27
All Medi-Cal PCPs & Specialists
Access Standards – Appointment Availability - PCPs & OB/GYNs
12/27
All PCPs & OB/GYNs
Access Standards – Appointment Availability - Specialists
12/27
All Specialists
NEW! State Fair Hearing and Independent Medical Review Forms added to D-SNP Letter Templates (Effective January 2, 2023)
12/27
All Medicare IPAs
REMINDER - Help Your Members Update Their Contact Information!
12/22
All PCPs
2022 GQ P4P PCP - Quality Bonus Services Code Update
12/22
All Medi-Cal PCPs & IPAs
UPDATED! D-SNP Letter Templates (Effective January 2, 2023)
12/21
All Medicare IPAs
Phase II Wave I– Prior Authorization Submission – January 20, 2023
12/21
Medi-Cal PCPs & Specialists
Crossing the Line - Examining Professional, Personal, & Ethical Boundaries
12/21
Riverside County PCPs & Specialists
IEHP Outbound Daily 834 Delta File Delay
12/20
All 834 Trading Partners
Revised UM Authorization Guidelines
12/19
All IPA Administrators & Medical Directors
REMINDER - IEHP DualChoice (HMO D-SNP) begins Jan 2023
12/19
All Medicare PCPs, Specialists & BH Providers
OB P4P Program - Early Postpartum Visit Update
12/19
All Medi-Cal OB/GYNs
My Life. My Choice. - An Online Advanced Care Planning Program
12/16
All Dual Choice PCPs
REMINDER - CoverMyMeds - Prior Authorization Submission Method for Dual Choice Members– Effective January 1, 2023
12/16
All Dual Choice PCPs & Specialists
IEHP 2022-2023 Holiday Hours
12/15
All Providers & IPAs
2022 Global Quality P4P Program – Data Submission Deadlines for PCPs!
12/15
All Medi-Cal PCPs
2022 Global Quality P4P Program – Data Submission Deadlines for IPAs!
12/15
All Medi-Cal IPAs
CORRECTION– New Fax Number for Physician Certification Statements for Non-Emergency Medical Transportation
12/09
All Hospitals and SNFs
Medicare Formulary Changes for 2023 IEHP DualChoice (HMO D-SNP)
12/08
All Medicare PCPs, Specialists & IPAs
Pharmacy Recalls, Withdrawals & Safety Alerts - November 2022
12/07
All PCPs
REMINDER - Physician Certification Statement (PCS) Requirement
12/06
All PCPs, Specialists, BH & IPAs
EVV Home Health Care Services Open Office Hours – December 16th
12/06
EVV Impacted Providers & Individual Nurse Practitioners
Mpox (formerly Monkeypox) Vaccine Available through Local Health Departments
12/05
All Medi-Cal PCPs & IPAs
IMPORTANT! DHCS Error – Members Will NOT be Disenrolled From IEHP
12/05
All Medicare PCPs & IPAs
Global Quality P4P PCP – 2022 Program Guide Update (Quality Bonus Services)
12/05
All Medi-Cal PCPs
The Alzheimer's Association Event - Resources for Improving Dementia Care in the Clinical Practice
12/02
All PCPs
CoverMyMeds - Prior Authorization Submission Method for Dual Choice Members– Effective January 1, 2023
12/02
All Dual Choice PCPs
REMINDER - IEHP Dual Choice (HMO D-SNP) begins Jan 2023
12/02
All Medicare PCPs, Specialists & BH Providers
Response Requested by December 6, 2022! - CBAS Emergency Remote Services - Reporting
12/02
All CBAS Providers
IEHP Formulary Changes - November P&T Update
12/02
All PCPs
November 2022 Pharmacy and Therapeutics Subcommittee Update
12/02
All PCPs
NEW! D-SNP Letter Templates - Claims (Effective January 2, 2023)
12/02
All Medicare IPAs
Effective Today! - IEHP Contracts with Call The Car For Transportation
12/01
All Hospitals & SNFs
COVID-19 Isolation in SNF
12/01
All SNFs
Living the Mission Awards Nomination Form
12/01
All IEHP Providers
November 2022
Inland Empire Community Health Assessment
11/30
All PCPs, IPAs, Specialists, & Behavioral Health Providers
Pharmacy Benefits Manager (PBM) Change for DualChoice (HMO D-SNP) - Member Outreach in Process
11/29
All DualChoice PCPs & Medicare IPAs
ID Cards with Errors Reissued to Dual Choice Members
11/23
Select Dual Choice PCPs
Inland Caregiver Resource Center Informational Webinar - ECHO
11/23
All PCPs
IEHP’s Quarterly Behavioral Health Provider Training
11/18
All Behavioral Health (BH) Providers
Thanksgiving Holiday
11/18
All IEHP Providers
IEHP Outbound Daily 834 Delta File Delay
11/18
All 834 Trading Partners
CoverMyMeds - Prior Authorization Submission Method for Dual Choice Members– Effective January 1, 2023
11/17
All IEHP DualChoice PCPs
IEHP DualChoice (HMO D-SNP) 2023 Vision Benefits
11/17
All Vision Providers
Riverside County Medical Association's Physician Holiday Social
11/17
All Riverside County PCPs & Specialists
RUHS - PHA - Early Respiratory Syncytial Virus (RSV) and Seasonal Influenza Activity
11/17
All Riverside County PCPs
Global Quality P4P PCP Meeting - 2023 Program Preview
11/16
All Medi-Cal PCPs
BHT (QASP) Provider Training
11/15
All BHT (QASP) Providers
Reminder - BH Emergency Instruction Standards
11/15
All BH Providers
Reminder - PCP and Specialist Emergency Instruction Standards
11/15
All PCPs & Specialists
UPDATE! D-SNP Letter Templates (Effective January 2, 2023)
11/15
All Medicare IPAs
UPDATE - Revised UM Authorization Guidelines to November 3, 2022 - UM-BH 08
11/14
All Medi-Cal IPAs & BHT Providers
Pharmacy Recalls, Withdrawals & Safety Alerts - October 2022
11/14
All PCPs
REMINDER: IEHP DualChoice (HMO D-SNP) begins Jan 2023
11/10
All Medicare PCPs, Specialists & BH Providers
REMINDER: Help Your Members Update Their Contact Information!
11/10
All IEHP PCPs
Maternal Wellness Event Flyer
11/09
All Medi-Cal PCPs, OB/GYNs, Peds, BH Providers & IPAs
Essure System - No Longer a Covered Benefit
11/09
All OB/GYNs
ACTION REQUIRED -Submit 2023 Provider Policy and Provider Manual Acknowledgement of Receipt (AOR) - Win a $50 Gift Card
11/08
All IEHP Providers
Veterans Day
11/04
All IEHP Providers & IPAs
Revised UM Authorization Guidelines
11/03
All BH Providers & IPAs
Pharmacy Recalls, Withdrawals & Safety Alerts - September 2022
11/02
All PCPs
October 2022
Medicare - Nondiscrimination Notice and Taglines Templates
10/31
All Medicare IPAs
REMINDER: IEHP Interpreter Services – A Covered Benefit!
10/31
All PCPs & IPAs
Continuous Glucose Monitors
10/28
All Medicare PCPs, Endocrinologists & IPAs
Health Education Classes Available in Riverside Area
10/27
All Riverside Area PCPs, Specialists & OBs
PHA - Outbreak of Ebola Virus Disease Due to Sudan Virus in Central Uganda
10/25
All Riverside County PCPs
834 Eligibility File Format Changes
10/25
All IHEP 834 Trading Partners
Global Quality P4P IPA Meeting – 2023 Program Preview
10/21
All Medi-Cal IPAs
REMINDER DHCS Hospice Rates – Prospective Calculation Based on Medicaid Rates
10/21
All Hospice Providers
NEW! D-SNP Letter Templates (Effective January 2, 2023)
10/21
All Medicare IPAs
Help Protect Your Members Against the Flu
10/20
All PCPs & IPAs
Public Health Emergency (PHE) Ending Soon – Help Your Members Reenroll!
10/19
All IEHP PCPs
REMINDER - Balance Billing of IEHP Members Not Permitted!
10/14
All IEHP Providers
ACTION REQUIRED - Correct Prioritization of Authorization Requests
10/14
All PCPs, Specialists & IPAs
Global Quality P4P PCP Meeting – 2023 Program Preview
10/13
All Medi-Cal PCPs
Flu Vaccine Notice -Access to Pharmacy Vaccine Network
10/13
All PCPs
Cal MediConnect Sunsets and IEHP Dual Choice (D-SNP) Begins
10/12
All PCPs
Academic Detailing Services Now Offered
10/11
All IEHP Providers & Pharmacies
REMINDER - ACTION REQUIRED - Electronic Visit Verification (EVV) Implementation Requirements – Self Registration Required by October 19, 2022
10/10
All Home Health Care Services (HHCS) Providers & Personal Care Services (PCS)
UPDATE - Independent Medical Review (IMR) Forms
10/10
All Medicare IPAs
UPDATE to September 8, 2022 Communication Authorization Timeframes
10/6
All Medi-Cal IPAs
Special Fraud Alert - Exercise Caution with Purported Telemedicine Companies
10/6
All IEHP Providers & IPAs
FAQs For Delegate Monitoring of Utilization Measures
10/5
All IPAs
September 2022
Global Quality P4P Programs – NEW 2022 Quality Bonus Services!
09/30
All Medi-Cal PCPs
Diversity Awareness Month - October 2022 - Please Join Us!
09/30
All IEHP Providers & IPAs
REMINDER - IEHP Coordination of Benefits Agreement (COBA) Implementation – Action Required!
09/30
All PCPs, Specialists, ANC & Hospitals
ICD-10-CM Risk Adjustment Code Changes for CMS HCC Code Capture
09/26
All Direct Dual Choice PCPs
UPDATE! – Continuous Glucose Monitoring (CGM) Systems (IPA)
09/23
All Medi-Cal IPAs
UPDATE! – Continuous Glucose Monitoring (CGM) Systems
09/22
All Medi-Cal PCPs & Endocrinologists
ACTION REQUIRED - Electronic Visit Verification (EVV) Implementation Requirements – Self Registration Required by October 19, 2022
09/22
All Home Health Care Services (HHCS) Providers & Personal Care Services (PCS)
UPDATED Medi-Cal Letter Templates
09/22
All Medi-Cal IPAs
URGENT ATTENTION: Phishing Email Alert
09/21
All IEHP Providers
Pharmacy Times - Medication Reconciliation
09/21
All Dual Choice PCPs
Grievance Process Updates - Grievance Summary Form - Due Date
09/15
All IPAs
Continuity of Care (COC) Rosters Now Available on SFTP
09/15
All IPAs
REMINDER - Enhanced Care Management Available for Members
09/15
All Medi-Cal ANC and Vision Providers
Coordination of Benefits Agreement (COBA) Implementation - Action Required
09/12
All PCPs, Specialists, ANC & Hospitals
REMINDER - Dilated Retinal Exam (DRE) for Diabetic Members
09/09
All PCPs & Vision Providers
Revised UM Authorization Guidelines
09/09
All IPA Administrators & Medical Directors
Annual BH&CM Medi-Cal IPA Training Survey
09/08
All Medi-Cal IPA Care Management Staff
IEHP Provider Portal Updates – Reports now Viewable by TIN
09/08
All Medi-Cal PCPs
NEW - Collecting Social Determinants of Health Data (SDOH)
09/08
All Medi-Cal PCPs, Specialists & BH Providers
Authorization Timeframes Notice of Action (NOA) Translation & Attachment
09/08
All Medi-Cal IPAs
Please Notify IEHP if Your Availability has Changed due to Area Fires
09/08
All Hemet and Big Bear Area Providers
Recalls, Withdrawals & Safety
09/08
All IEHP Providers & Pharmacies
IEHP Formulary Changes (P&T)
09/07
All IEHP PCPs
Access Standards - Appointment Availability - Specialists
09/02
All Specialists
Access Standards - Appointment Availability - PCP, Ob
09/02
All PCPs & Obs
Access Standards - Appointment Availability - BH
09/02
All Behavioral Health Providers
Vaccination Clinic and Resource Fair - September 10
09/02
All Direct PCPs
IEHP Medi-Cal Medical Benefit Formulary
09/02
All Medi-Cal PCPs, Specialists & Psychiatrists
August 2022 P&T Update
09/02
All IEHP Providers & Pharmacies
August 2022
2022 - 2023 Flu Vaccination for IEHP Members
08/31
All IEHP Providers & Pharmacies
REMINDER: Medi-Cal Rx Gradual Reinstatement of PAs – Phase 1
08/31
All Medi-Cal PCPs & Specialists
Labor Day Holiday
08/30
All IEHP Providers & IPAs
REMINDER: Enhanced Care Management Available for Members
08/30
All Medi-Cal PCPs & IPAs
Final REMINDER: Submit the 2022 Provider Satisfaction Survey
08/29
All PCPs, Specialists & BH Providers
REMINDER: Community Supports Services Available for Members
08/29
All PCPs, Specialists & BH Providers
Medication Reconciliation Program
08/29
All IEHP Providers & Pharmacies
NOTICE: DHCS Approved Letter – Prior Authorization Not Required
08/26
All Medi-Cal IPAs
NOTICE: DHCS Approved Letter – Prior Authorization Not Required
08/26
All Medi-Cal PCPs, Specialists & Ambulatory Surgery Centers
REMINDER: Aug 2022 Provider Educational Series: “How to Navigate Rosters & Reports”
08/24
All Direct Medi-Cal PCPs
NEW: Health Education Classes Offered in Desert Hot Springs and Mecca
08/24
All Coachella Valley PCPs
ADVISORY: Updated Monkeypox Guidance
08/23
All Riverside County PCPs
San Bernardino County Public Health - Monkeypox Guidance
08/23
All San Bernardino County PCPs & Specialists
REMINDER: Medication Reconciliation
08/22
All IEHP Providers
REMINDER: 2022 Provider Satisfaction Survey
08/22
All PCPs, Specialists, & BH Providers
REMINDER: DHCS Quarterly Timely Access Survey
08/22
All Medi-Cal PCPs, Specialists, BH & Ancillary Providers
Medication Reconciliation Program
08/22
All IEHP Providers & Pharmacies
Reinstatement of PA Requirements for 11 Drug Classes
08/17
All Medi-Cal PCPs
REMINDER: Appropriate Billing for Dispensing of Vision Materials
08/17
All Vision Providers
REMINDER: Provider Directory Verification Form due August 26th
08/17
Select PCPs & Specialists
Medication Reconciliation Program
08/15
All IEHP Providers & Pharmacies
REMINDER: Timely Provision of Denial Packets
08/12
All Medicare IPAs
Member Grievance Updates: Medical Record Requests
08/12
All Direct PCPs, Specialists, & Ancillary
2022 Global Quality P4P Program Guide Updates - SDOH Rate Measure
08/12
All Medi-Cal PCPs & IPAs
Medi-Cal Letter Templates
08/11
All Medi-Cal IPAs
Recalls, Withdrawals & Safety
08/10
All IEHP Providers & Pharmacies
UPDATE: IEHP’s Network is Open to New QASP Providers
08/08
All BHT Providers
2022 Provider Educational Series – How to Navigate Rosters & Reports
08/08
All Direct Medi-Cal PCPs
Proposition 56 – Don’t Miss Out on Available Supplemental Payments
08/05
All Medi-Cal PCPs
2022 Provider Quality Resource Guide
08/05
All PCPs
Changes to Quarterly Workplan Requirements
08/03
All IPAs
REMINDER: Provider Preventable Conditions - Reporting Requirements
08/03
All IEHP Providers, Ambulatory Surgical Centers & IPAs
Webinar: COVID-19 In the Black and Brown Community and the Post Long-Term Effects
08/01
All PCPs & IPAs
Medication Reconciliation Program
08/01
All IEHP Providers & Pharmacies
July 2022
NEW DATE: Medi-Cal Rx Gradual Reinstatement of Prior Auths (PAs) – Phase 1 – September 16, 2022
07/29
All Med-Cal PCPs & Specialists
Practitioner Reporting Requirements - UB-04 Claim Form
07/29
All SNFs, Hospitals, & Ancillary
Free Webinar: It Takes a Village to Manage COVID-19
07/27
All PCPs & IPAs
REMINDER: Medi-Cal Rx Gradual Reinstatement of PAs – Phase 1 – August 1, 2022
07/25
All Medi-Cal PCPs & Specialists
ALERT: Hospice Policy and Procedures
07/25
Select Contract and Non-Contracted Hospice Providers
Inappropriate Treatment Delays and Denials for HIV PrEP and PEP
07/22
All Medi-Cal PCPs & Specialists
UPDATED: Telehealth Services FAQs
07/21
All PCPs, Specialists, BH, BHT Providers & IPAs
2022 Global Quality P4P Program – Provider Directory Verification
07/20
All Medi-Cal PCPs
NEW: Riverside County Public Health: Updated Monkeypox Guidance
07/20
All Riverside County PCPs & Specialists
DHCS Plan Data Feed Project – Files Available on SFTP
07/19
All IPAs
2022 Global Quality P4P PCP Program Guide- UPDATES
07/18
All Medi-Cal PCPs
2022 Global Quality P4P IPA Program Guide- UPDATES
07/18
All Medi-Cal IPAs
2022 Appointment Availability Survey – Fax Survey
07/15
All PCPs & IPAs
2022 Appointment Availability Survey – Fax Survey
07/15
All BH Providers
2022 Appointment Availability Survey – Fax Survey
07/14
All Specialists, Ancillary & IPAs
UPDATE: Diabetic Vision Outreach Campaign – EXTENDED to July 22, 2022
07/14
All Vision Providers
Medi-Cal Rx Gradual Reinstatement of PAs – Phase 1
07/11
All Medi-Cal PCPs & Specialists
2022 Global Quality P4P (GQ P4P) Interim Reports Data Refresh
07/11
All Medi-Cal PCPs & IPAs
Update: Risk Adjustment Telehealth and Telephone Services
07/11
All Dual Choice PCPs, Specialists & BH Providers
Cal MediConnect Sunsets and IEHP Dual Choice (D-SNP) Begins
07/08
All Medicare PCPs, Specialists & BH Providers
2022 Provider Satisfaction Survey
07/07
All PCPs, Specialists & BH Providers
2022 Provider Educational Series - Provider Directory Verification Process (Virtual)
07/07
All Medi-Cal PCPs
Recalls, Withdrawals & Safety
07/07
All IEHP Providers & Pharmacies
IEHP Medi-Cal Medical Benefit Formulary
07/01
All Medi-Cal PCPs, Specialists & Psychiatrists
IEHP Providers Can Post Jobs and Find Candidates for Free on SoCalDocJobs.com
07/01
All PCPs
June 2022
ALERT: No Prior Authorization for Biomarker Testing for Stage 3 and 4 Metastatic Cancers
06/29
All PCPs, Specialists & IPAs
REMINDER – KidVaxGrant Application Deadline Approaching
06/29
All Medi-Cal PCPs
REMINDER - 2022 Provider Educational Series: Provider Directory Verification Process
06/28
All Direct Medi-Cal PCPs
DHCS Plan Data Feed Project
06/27
All IPAs
Alzheimer’s and Dementia Care: A FREE CME Project Echo Opportunity
06/27
All IEHP Family Practice & Internal Medicine Providers
Independence Day Holiday
06/27
All IEHP Providers & IPAs
Standards for Determining Threshold Languages, Nondiscrimination Requirements, and Language Assistance Service
06/27
All Medi-Cal IPAs
UPDATED - Telehealth Services POS Code Updates
06/26
All PCPs, Specialists & BH Providers
Clinical Practice Guidelines
06/24
All PCPs & IPAs
Access Standards – Appointment Availability for Specialists
06/24
All Specialists
NOTICE: No Prior Authorizations for Preventive Services - IPAs
06/23
All Medi-Cal IPAs
NOTICE: No Prior Authorizations for Preventive Services - Providers
06/23
Direct Medi-Cal PCPs & Specialists
Billing of IEHP Members Guidance
06/22
All IEHP Providers & IPAs
May 2022 P&T Update
06/22
All IEHP Providers & Pharmacies
REMINDER - 2022 Provider Educational Series: Provider Directory Verification Process
06/21
All Direct Medi-Cal PCPs
Access Standards – Appointment Availability for PCPs and OB Providers
06/21
All PCPs & OB Providers
Access Standards – Appointment Availability for BH Providers
06/21
All Behavioral Health Providers
REMINDER – Authorizations Required for All Follow-up Visits!
06/17
All BH & BHT Providers
REMINDER: 2022 Global Quality P4P Program – CAIR2 Participation Requirement
06/17
All Medi-Cal PCPs
Member Campaign on Preventive Care Services
06/17
All Medi-Cal PCPs & IPAs
Updates/Amendments to AB 1184: Confidential Communication of Medical Information Involving Sensitive Services
06/16
All Medi-Cal Providers & IPAs
IEHP Alternative Format Requirement Overview
06/14
All IEHP Providers & IPAs
Juneteenth Holiday
06/13
All IEHP Providers & IPAs
REMINDER - Authorizations Required for Vision Services
06/10
All Vision Providers
Alcohol and Drug Screening Assessment Brief Interventions and Referral to Treatment (SABIRT)
06/10
All PCPs & IPAs
2022 Provider Educational Series - Provider Directory Verification Process
06/10
All Direct Medi-Cal PCPs
Navigating the Formula Crisis Webinar
06/08
All Medi-Cal PCPs & OB/GYN
MTM Medi-Cal Provider Mailing Campaign
06/08
All IEHP Providers & Pharmacies
MTM Medicare Provider Mailing Campaign
06/08
All IEHP Providers & Pharmacies
Recalls, Withdrawals & Safety
06/05
All IEHP Providers & Pharmacies
Academic Detailing Services Now Offered
06/04
All IEHP Providers & Pharmacies
Medi-Cal Rx Billing Policy for Physician Administered Drugs (PADs)
06/03
All Medi-Cal PCPs, Specialists & IPAs
New and Revised UM Authorization Guidelines
06/03
All IPA & BHT Providers
UPDATES COMING SOON – Changes to UM Semi-Annual and Annual Reporting Requirements
06/01
All IPAs
UPDATE - Facility Site Review (FSR) and Medical Record Review (MRR) Tools and Standards – Effective July 1, 2022
06/01
All PCPs & IPAs
May 2022
IEHP’s Bi-Annual BHT Provider Training
05/27
All Behavioral Health Treatment (BHT) Providers
Memorial Day Holiday
05/23
All Providers & IPAs
REMINDER: CMC Transition to D-SNP - Model of Care Early Preview Meeting - June 13, 2002
05/23
All IPA CM & Quality Staff
2022 Global Quality P4P Program - NEW 2022 Interim Reports
05/20
All Medi-Cal PCPs
IEHP UM Department Availability
05/20
All PCPs, Specialists & BH
Care Coordination REMINDER – Review the Early Start Roster on IEHP’s Portal
05/17
All Medi-Cal PCPs & IPAs
CMC Transition to D-SNP - Model of Care Early Preview Meeting - June 13, 2002
05/16
All IPA CM & Quality Departments
REMINDER: 2022 Global Quality P4P Program – CAIR2 Participation Requirement
05/16
All Medi-Cal PCPs
REMINDER: 2022 Global Quality P4P Program – Manifest MedEx Connectivity
05/16
All Medi-Cal PCPs
eReferral Submission to IEHP now available for IPA assigned Medi-Cal Members: Transplants (MOT) and Community Support Services
05/13
All Medi-Cal PCPs & IPAs
Applied Changes for Medicare Members on the 835 Files
05/10
IEHP Trading Partners
Sunsetting of Proposition 56: Value Based Payment Program
05/09
All Medi-Cal PCPs, Specialists, BH & IPAs
HIV/AIDS Specialist Survey
05/06
All Specialists
UPDATED FAQs: Members with Other Health Coverage (OHC)
05/06
All Providers & IPAs
Revised/Retired UM Authorization Guidelines
05/06
All Medi-Cal IPAs & BH
Community Supports Services Modifier Guidance
05/06
All Medi-Cal PCPs, Specialists, BH & IPAs
Recalls, Withdrawals & Safety Alerts
05/05
All IEHP Providers & Pharmacies Providers
REMINDER: No Prior Authorizations Needed for Preventive Services
05/03
All IPAs
Alzheimer’s and Dementia Care: A Project Echo Opportunity
05/03
All PCPs
Webinar - IWIN COVID and the Community
05/02
San Bernardino County PCPs
April 2022
2022 Global Quality P4P Program - Manifest MedEx Connectivity Reminder
04/29
All Medi-Cal PCPs
Maternal Wellness Events - May 2022 - IEHP Community Resource Centers
04/28
All Medi-Cal PCPs, OB/GYN, Peds, BH & IPAs
Letter to Primary Care Providers RE-Response to GSF
04/27
All Medi-Cal PCPs
Letter to Providers RE-Response to GSF
04/26
All Medi-Cal IPAs & Specialists
Initial Health Assessment (IHA) Roster
04/22
All Medi-Cal PCPs & IPAs
REMINDER: IEHP Interpreter Services – Benefit for Members!
04/20
All PCPs & IPAs
REMINDER - 2022 Global Quality P4P Program – CAIR2 Participation Requirement
04/15
All Medi-Cal PCPs
COVID-19 “Test to Treat” Initiative
04/13
All PCPs & IPAs
Revised UM Authorization Guideline
04/12
All Medi-Cal IPA Administrators and Medical Directors & BH Providers
Public Health Service (PHS) 340B Participating Provider Billing Reminder
04/12
All FQHCs and DSHs
Care Plans and Health Risk Assessments (HRAs) Reminder
04/08
All PCPs, Specialists, SNFs & CBAS
2nd Round of Free At-Home COVID-19 Test Kits Available
04/08
All Medi-Cal PCPs
Misdirected Claims Testing – Meeting Request
04/07
IEHP Trading Partners
Alzheimer’s and Dementia Care: A Project Echo Opportunity
04/06
All IEHP PCPs
Standing Orders Enrollment - Respond Today!
04/06
All Medicare PCPs
Medicare P4P IEHP Direct – Blood Pressure Control Billing Guidance
04/05
All Direct DualChoice PCPs
Important Notice: Proton Pump Inhibitor Overutilization
04/05
All IEHP Providers & Pharmacies
Recalls, Withdrawals & Safety Alerts
04/05
All IEHP Providers & Pharmacies
March 2022
CORRECTION - Standing Orders Enrollment- Respond Today!
03/31
All Medi-Cal PCPs
Complex Case Management (CCM) Program – Severe Chronic Conditions
03/30
All Medi-Cal PCPs, Specialists, BH Providers & IPAs
Major Organ Transplants (MOT) and TAR Approval DATE Impact
03/29
All Medi-Cal IPAs & COEs
Standing Orders Enrollment - Respond Today!
03/29
All Medi-Cal PCPs
MTM Medi-Cal Provider Mailing Campaign
03/29
All IEHP Providers & Pharmacies
MTM Medicare Provider Mailing Campaign
03/29
All IEHP Providers & Pharmacies
Initial Health Assessment (IHA)
03/28
All Medi-Cal PCPs
REMINDER - 2022 OB P4P Kickoff Meeting – March 31, 2022!
03/28
All Medi-Cal OB/GYNs
CMS Signature Requirement Guidelines for Member Medical Records
03/25
All IPAs, PCPs, Specialists & BH Providers
REMINDER: IEHP Claims, Appeals/Disputes and Audit Recovery Mailing Addresses
03/25
All Direct PCPs, Specialists & BH Providers
2021 GQ P4P Program- Data Submission Extension Until March 31, 2022
03/22
All Medi-Cal PCPs
REMINDER: IEHP Wants to Know Your Interest in Pilot Program to Implement a Community Electronic Health Record (EHR)
03/22
All Medi-Cal PCPs
REMINDER - American Rescue Plan Act – Extension of Postpartum Care Coverage
03/21
All Medi-Cal PCPs, OBs & IPAs
Behavioral Health Access Standards – Appointment Availability
03/16
All Behavioral Health Providers
New DHCS DUR Board Educational Article
03/16
All IEHP Providers & Pharmacies
IEHP Wants to Know: Interest in Pilot Program to Implement a Community Electronic Health Record (EHR)?
03/15
All Medi-Cal PCPs
REMINDER - 2022 Global Quality P4P Program – CAIR2 Participation Requirement
03/14
All Medi-Cal PCPs & IPAs
Riverside County Legionnaires' Disease Advisory
03/14
All PCPs & IPAs
Coordination of Benefits with Other Health Coverage (OHC) – Medi-Medi Coverage Added to Provider Portal
03/11
All IEHP Providers & IPAs
Notice of Dismissal of Coverage Letter Updates & Attestation Form
03/11
All Medicare IPAs
Process for IEHP Medi-Cal Members: Continuous Glucose Monitors (CGM)
03/10
All Medi-Cal PCPs
UPDATED Integrated Denial Notice Medicare Letter Templates
03/08
All Medicare IPAs
Process for IEHP Medi-Cal Members: Blood Pressure Monitors and Nebulizers
03/07
All Medi-Cal PCPs
Recalls, Withdrawals & Safety Alerts
03/07
All IEHP Providers & Pharmacies
IEHP’s Quarterly BH Provider Training
03/04
All Behavioral Health Providers
Update: Enhanced Care Management Roster Available on Provider Portal
03/01
All Medi-Cal PCPs & IPAs
You will need Adobe Acrobat Reader 6.0 or later to view the PDF files. You can download a free copy by clicking here.
MediCal - Facility Site Review
th us to offer our members the highest quality care and service they need. Facility Site Reviews are the required standards by the California Department of Health Care Services (DHCS)/Medi-Cal Managed Care Division (MMCD) for all primary care provider (PCP) sites. Below you will find various resources in regards to DHCS information, Physical Accessibility Reviews (PARS), Facility Site Review (FSR), and Medical Record Reviews (MRR) as well as IEHP’s addendum tools for your reference.
Facility Site Review Training Index:
Department of Health Care Services (DHCS)
IEHP Addendum Tools
PARS
Facility Site Review
Medical Record Review
Department of Health Care Services (DHCS)
2022 Facility Site Review Standards (FSR) (PDF)
2022 Facility Site Review Tool (FSR) (PDF)
2022 Medical Record Review Standards (MRR) (PDF)
2022 Medical Record Review Tool (MRR) (PDF)
APL 22-017 - Facility Site Review and Medical Record Review (PDF)
DPL 14-005 - FSR Physical-Accessibility Reviews (PDF)
PL 12-006 - Revised FSR Tool (PDF)
(Back to Index)
IEHP Addendum Tools
Att 06 - IEHP Urgent Care Evaluation Tool (PDF)
IEHP Interim Review (PDF)
(Back to Index)
PARS
APL with PARS C (PDF)
APL with PARS D & CBAS (PDF)
PAR-FSR-C_PARS - Survey (PDF)
PAR-FSR-D_PARS - Ancillary (PDF)
PAR-FSR-E_PARS - CBAS (PDF)
(Back to Index)
Facility Site Review Menu
Click on the following links to jump to that specific section:
Facility Site Review Audit Tool Sections
Additional Documents
Medical Record Review Audit Tool Sections
Additional Documents
(Back to Index)
Access/Safety
Facility Site Review
Pre-filled Emergency Medications Dosage Chart (PDF)
Emergency Exit Routes Factsheet (PDF)
Evacuation Routes (PDF)
Glucometer Log (PDF)
Hemocue Log (PDF)
Medical Emergency, Earthquake, Fire Protocols (PDF)
Sample of Sizes of Ambu Bags (PDF)
Sample Oxygen Tank Set (PDF)
Workplace Violence (PDF)
(Back to FSR Menu)
Adult Preventive
Medical Record Review
ACES Screening (PDF)
Adult Health History (PDF)
Adult Sterilization & Special Consent P&P (PDF)
Alcohol Resources (PDF)
AUDIT-C (PDF)
Brief Addiction Monitor (BAM) (PDF)
Comprehensive Pediatric and Adult Health Assessment Forms (PDF)
CRAFFT-2.0 Clinician Interview (PDF)
Hepatitis Risk Assessment Tool (PDF)
Intimate Partner Violence (IPV) Screening Tools (PDF)
Intimate Partner Violence (IPV) and Sexual Violence Victimization Assessment Instruments for Use in Healthcare Settings (PDF)
PHQ-2 - Sample (PDF)
PHQ-9 - Sample (PDF)
Required Documentation Checklist for Adult (PDF)
Social Needs Screening Tool (PDF)
TB Risk Assessment Adult (PDF)
(Back to FSR Menu)
Clinical Services
Facility Site Review
Checklist for Safe Vaccine Storage and Handling (PDF)
Clean and Dirty Sign (PDF)
Controlled Substance Distribution Log (PDF)
Controlled Substance Narcotic Log (PDF)
Monthly Expiration Date & Verification Log (PDF)
P&P Distribution of Sample Medications (PDF)
Patient Distribution Log for Samples (PDF)
Plan for Vaccine Protection in Case of Power Outage (PDF)
Radiology - Notice to Employees (PDF)
Sample Radiology Inspection Report (PDF)
Vaccine Information Sheet (VIS) Protocol (PDF)
Vaccine Storage (PDF)
(Back to FSR Menu)
Coordination of Care
Medical Record Review
Adult Progress Note - Sample (PDF)
Missed Appointment Log - Sample (PDF)
Pediatric Progress Note - Sample (PDF)
(Back to FSR Menu)
Documentation
Medical Record Review
Adult General Consent to Treat (PDF)
Advance Health Care Directive Acknowledgement Form (PDF)
CAIR Sharing Request (PDF)
General Consent to Treat Minor (PDF)
Medical Record Release (PDF)
Sample Medication List (PDF)
Signature Page - IEHP (PDF)
(Back to FSR Menu)
Format
Medical Record Review
Acknowledgment of Receipt of Notice of Privacy Practice (PDF)
(Back to FSR Menu)
Infection Control
Facility Site Review
AAP Infection Prevention and Control in Pediatric Ambulatory Settings - COVID (PDF)
Autoclave Log (PDF)
Biohazardous Sign (PDF)
Bloodborne Pathogens & Post Exposure Plan - Fillable (PDF)
Cleaning Schedule (PDF)
Communicable Disease (ISOLATION) Protocol (PDF)
Infection Control, Biohazardous Waste and Disposition of Patients with Contagious Disease (PDF)
Instrument Transportation Log (PDF)
Isolation & Transmissions Based Precautions (PDF)
OSHA Employee Injury Report Form (PDF)
P&P Autoclave (PDF)
P&P Autoclaving Instruments in Peel (PDF)
P&P Chemical Disinfection (PDF)
P&P Cold Sterilization (PDF)
P&P Transport for Reusable Instruments (PDF)
Reusable Sharps Container (PDF)
Safety Needle Fact Sheet (PDF)
Sharps Injury Log Sample (PDF)
Transfer Stations and Treatment Facilities (PDF)
(Back to FSR Menu)
OB/CPSP Preventive
Medical Record Review
CPSP Initial and Trimester Assessment and Care Plan (PDF)
CPSP Postpartum Assessment and Care Plan (PDF)
Edinburgh Postnatal Depression Scale (EPDS) (PDF)
Required Documentation Checklist for OB (PDF)
(Back to FSR Menu)
Office Management
Facility Site Review
Access Standards (PDF)
After Hour Script (PDF)
CLAS Standards (PDF)
Confidentiality Form (PDF)
Fax Sheet (PDF)
Medical Emergency, Earthquake, Fire Protocols (PDF)
Medical Record Release (PDF)
Office Hours Sample Form (PDF)
On-Call Provider Schedule (PDF)
PCP Referral Tracking Log (PDF)
Referral Process (PDF)
Sample Office Hours (PDF)
Wait Time Survey Tool (PDF)
(Back to FSR Menu)
Pediatric Preventive
Medical Record Review
AAP Infection Prevention and Control in Pediatric Ambulatory Settings - COVID (PDF)
AAP Schedule (PDF)
AAP Supplemental Information (PDF)
Alcohol Resources (PDF)
AUDIT-C (PDF)
Brief Addiction Monitor (BAM) (PDF)
CDC BMI Growth Chart - Boys (PDF)
CDC BMI Growth Chart - Girls (PDF)
CDC Growth Chart Head Circumference - Boys (PDF)
CDC Growth Chart Head Circumference - Girls (PDF)
CDC Growth Chart Weight for Age - Boys (PDF)
CDC Growth Chart Weight for Age - Girls (PDF)
Child Health History - English (PDF)
Child Health History - Spanish (PDF)
Comprehensive Pediatric and Adult Health Assessment Forms (PDF)
CRAFFT-2.0 Clinician Interview (PDF)
Edinburgh Postnatal Depression Scale (EPDS) (PDF)
General Consent to Treat Minor (PDF)
Hepatitis Risk Assessment Tool (PDF)
Intimate Partner Violence (IPV) Screening Tools (PDF)
Intimate Partner Violence (IPV) and Sexual Violence Victimization Assessment Instruments for Use in Healthcare Settings (PDF)
PEARLS Assessment (PDF)
PEARLS Teen Self-Assessment (PDF)
PHQ-2 - Sample (PDF)
PHQ-A - Sample (PDF)
Required Documentation Checklist for Pediatric (PDF)
Social Needs Screening Tool (PDF)
TB Risk Assessment Pediatrics (PDF)
What Do You Eat (8-19 years) - English (PDF)
What Do You Eat (8-19 years) - Spanish (PDF)
What Does Your Child Eat (Birth - 8 years) - English (PDF)
What Does Your Child Eat (Birth - 8 years) - Spanish (PDF)
Youth Nutrition and Activity Assessment (8 - 19 years) (PDF)
(Back to FSR Menu)
Personnel
Facility Site Review
Accessibility Obligations of Medical Practices (PDF)
Bloodborne Pathogens & Post Exposure Plan - Fillable (PDF)
Domestic Violence (PDF)
Electronic Resources for Required Employee Training (PDF)
Employee File Checklist (PDF)
IEHP Cultural and Linguistics Training (PDF)
IEHP Evidence of Staff Training (PDF)
IEHP Grievance Resolution Process - English (PDF)
IEHP Grievance Resolution Process - Spanish (PDF)
IEHP P&P Child Abuse Reporting (PDF)
IEHP P&P Elder or Adult Abuse Reporting (PDF)
IEHP P&P Sensitive Services-Access Standards (PDF)
Medical Assistant Letter of Competency - Fillable (PDF)
Medical Assistant Venipuncture Form (PDF)
Medication Administration Procedures (PDF)
Mid-level Supervision of Medical Assistant (PDF)
Notice to Consumer PA Sign - English (PDF)
Notice to Consumer PA Sign - Spanish (PDF)
Notice to Consumer Sign - English (PDF)
Notice to Consumer Sign - Spanish (PDF)
SB697 Practice Agreement (PDF)
SOC 341 (PDF)
Standardized Procedures for Nurse Practitioner (PDF)
Suspected Child Abuse Report (PDF)
(Back to FSR Menu)
Preventive Services
Facility Site Review
Pure Tone Audiometer (PDF)
Sample Eye Chart (PDF)
(Back to FSR Menu)
Additional Documents
Facility Site Review
IEHP Phone List (PDF)
(Back to FSR Menu)
Additional Documents
Medical Record Review
Online Resources for Medical Record Review (PDF)
(Back to FSR Menu)
You will need Adobe Acrobat Reader 6.0 or later to view the PDF files. You can download a free copy by clicking here.
MediCal - Safety Practices
om the market because it is found to be either defective or potentially harmful. The FDA along with pharmaceutical companies monitors medications out on the market for unforeseen problems. If an issue is identified, or the safety of the medication becomes a concern, a recall is initiated.
Information provided below are important new safety information regarding drug recalls. If you are taking a medication that has been recalled, please talk to your health care providers about the best course of action.
Date
03/15/2023
Class I Recall
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer
Purely Soothing 15% MSM Drops
Class II Recall
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only
Purely Soothing MSM Nasal Spray, 15%
NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula
NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine
NaturalCare bioAllers, Mold, Yeast and Dust
NaturalCare, children's, Allergy Care
Alcolado Relampago (menthol 1%, camphor 1.5%)
Vencedor medicated balm (capsaicin 0.028%)
Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%)
Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%)
Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin)
Activator Concentrate (sodium fluoride 0.96% in Activator)
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%)
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only
Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/08/2023
Class I Recall
PrimeZEN Black 2000mg
Class II Recall
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only
Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only
Aripiprazole Tablets, USP 2 mg, Rx Only
Aripiprazole Tablets, USP 5 mg Rx Only
Aripiprazole Tablets, USP 10 mg Rx Only
Aripiprazole Tablets, USP 15 mg Rx Only
Aripiprazole Tablets, USP 20 mg Rx Only
Aripiprazole Tablets, USP 30 mg Rx Only
Atorvastatin Calcium Tablets USP, 10 mg* Rx Only
Atorvastatin Calcium Tablets USP 20 mg* Rx Only
Atorvastatin Calcium Tablets USP 40 mg* Rx Only
Atorvastatin Calcium Tablets USP 80 mg* Rx Only
BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only
BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only
BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only
Clopidogrel Tablets USP, 75 mg, Rx Only
Daptomycin for Injection 350 mg/vial, Rx only
Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only
Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only
Doxazosin Tablets USP 1 mg, Rx Only
Doxazosin Tablets USP, 2 mg, Rx Only
Doxazosin Tablets USP, 4 mg, Rx Only
Doxazosin Tablets USP, 8 mg, Rx Only
Finasteride Tablets USP, 1 mg, Rx Only
Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only
Finasteride Tablets USP, 5 mg, Rx Only
Glimepiride Tablets USP, 1 mg, Rx Only
Glimepiride Tablets USP, 2 mg, Rx Only
Glimepiride Tablets USP, 4 mg, Rx Only
Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only
Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only
Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only
Montelukast Sodium Tablets, USP, 10 mg* Rx Only
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only
Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only
Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial
Rosuvastatin Tablets, USP, 5 mg*, Rx Only
Rosuvastatin Tablets, USP, 10 mg*, Rx Only
Rosuvastatin Tablets, USP 20 mg* Rx Only
Rosuvastatin Tablets, USP 40 mg* Rx Only
Simvastatin Tablets USP 5 mg Rx Only
Simvastatin Tablets, USP, 10 mg, Rx Only
Simvastatin Tablets USP 20 mg Rx Only
Simvastatin Tablets USP 40 mg Rx Only
Simvastatin Tablets USP 80 mg Rx Only
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only
Tadalafil Tablets, USP, 2.5 mg Rx Only
Tadalafil Tablets, USP, 5 mg Rx Only
Tadalafil Tablets, USP 10 mg Rx Only
Tadalafil Tablets, USP, 20 mg, Rx Only
Vigabatrin for Oral Solution, USP, 500 mg, Rx Only
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only
Pirfenidone Tablets 801 mg, Rx Only
Pravastatin Sodium Tablets USP, 10 mg, Rx Only
Pravastatin Sodium Tablets USP 20 mg, Rx Only
Pravastatin Sodium Tablets USP, 40 mg, Rx Only
Pravastatin Sodium Tablets USP, 80 mg, Rx Only
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only
rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only
rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only
rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only
rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only
rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only
Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/03/2023
Class I Recall
15% MSM Drops (Pharmedica USA LLC)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/02/2023
Class II Recall
Brimonidine Tartrate Ophthalmic Solution, 0.15%
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/01/2023
Class I Recall
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only
Class II Recall
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only
Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/24/2023
Class I Recall
Artificial Eye Ointment (Global Pharma Healthcare)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/22/2023
Class II Recall
Sodium Chloride 0.9% used as a diluent or hydration packaged volume of (a)1000ML (b)2000ML (c) 720ML used with Curlin pump, no pump or gravity
Amikacin 450MG in NS 45ml
Ampicillin 12 gm in NS 600m
Ampicillin 8 gm in NS 400ml
Ampicillin/Sulbactam 3gm in NS 100ml
Caspofungin 50mg in NS 100ml
Cefazolin (a) 12gm in NS 600ml, (b) 2gm in NS 100ml, (c) 2gm/20ml SW Syringe, (d) 3gm in NS 150ml
Cefazolin 5mg/mL/Heparin 100unit/ml 1.5ml SYR
Cefepime (a) 2gm in NS 100ml (b) 8gm in NS 400ml (c) 12gm in NS 600ml
Cefoxitin (a) 1gm in NS 50ml,(b) 2gm in NS 100ml
Ceftriaxone (a) 1gm in NS 50ml, (b) 4gm in NS 200ml, (c) 8gm in NS 400ml
Ceftriaxone (a) 2gm in NS 100ml, (b) 4gm in NS 200ml, Antibiotic
D5 NS 2300ml
D5W1/2NS W/ 77MEQ of Sod Acetate 1000ml Hydration
Daptomycin (a) 360mg in NS 18ml syringe (b) 580mg in NS 29ml syringe (c) 630mg in NS 31.5ml
Daptomycin (a) 400mg in NS 20ml, (b) 550mg in NS 27.5ml
Dextrose 10% 720ml, TPN
Diphenhydramine 18mg in 3.6ml NS Syringe
Dobutamine (a) 1080mg IN D5W 270ml, (b) 760mg in D5W 190ml
Ertapenem (Invanz) 1gm NS 100ml
Ethanol 70% 0.5ml Syringe
Fluconazole 200mg NS 100ml
Ganciclovir (Cytovene) (a)1480mg in NS 296ml, (b) 740 mg in NS 336ml
Hydrocortisone 9a) 2mg in NS 0.2ml Syringe, 9mg in NS 2ml Syringe
Hydromophone (a) 1mg/ml in NS, 50ml, 75ml, 100ml, 175ml; (b) 5mg/ml in NS 60ml, 100ml, 250ml
Imipenem/cilastatin 2000mg in NS 400mml
Intralipid 18gm TPN
Kytril 350mcg in 3.5ml NS Syringe
Lactated Ringers packaged in volume of 1000ml, 2500ml, 3000ml, 3600ml, 500ml hydration
Levaquin 750mg in D5W 150ml
Levothyroxine 25mcg in NS 1.25ml Syringe
Meropenem (a) 1000mg in NS 250ml, (b) 2gm in NS 100ml (c) 500mg in NS 125ml
Methadone (a) 2.5mg in 5ml NS syringe, (b) 4mg in 5ml NS syringe
Methylprednisolone 12mg in NS 1.2ml syringe
Metronidazole 500mg 100ml
Milrinone
Morphine Sulfate (a) 1mg/ml in NS 350ml (b) 5mg/ml in NS 200ml
Mycamine 100mg in NS 100ml
Nafcillin 24gm in NS 1200ml
Nalbuphine (a) 1.5mg in 1.5ml NS (b) 2.5mg in 2.5ml NS Syringe
Ondansetron 8mg in NS 100ml
Pantoprazole 30mg in NS 7.5ml Syringe
Penicillin (a)40mu in D5W 400ml(continuous) (b)40u in D5W 400ml (continuous) (c)48mu in D5W 480ml
Piperacillin/Tazobactam (a)4.5gm in NS 100ml (b)18gm in NS 267m (c)27gm in NS 400ml (d)3.375gm in NS 50ml (e)36 gm in NS 533ml
Sodium Chloride 0.9 % (a)100ml (Magnesium) (b)69.3ml (c)71.4ml (d)77.7ml (e)130ML (f)210ml (g)190ml (h)220ml: diluent
Tobramycin 660mg in NS 66ml
TPN (a)100gm/AA, 285gm/DEX (b)55gm/LIP 2300ml (c)55gm/AA 285gm/DEX 50gm/LIP1800ml (d)TPN AA:100gm DEX:250gm LIP:50gm 2400ml (e)55gm DEX:285gm 1800ml
TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL (b)108gm/AA, 330gm/DEX 3000ml (c)108gm/AA, 330gm/DEX, 60gm/LIP 3000ml (d)37gm/AA, 160gm/DEX 1450ml (e)37gm/AA, 160gm/DEX, 25gm/LIP 1450ml (f)74-100gm of protein B4197 74gm (g)75fm/AA, 200gm/DEX, 43gm/LIP 2500ml (h)90gm/AA ; 255gm/DEX ; 50gm/LIP 3500ml (i)90gm/AA ; 255gmDEX 3500ml (j)TPN AA 100gm DEX: 320gm LIP: 50gm 2400ml (k)TPN AA 30gm DEX: 145gm 1210ml (l)TPN AA 30gm DEX: 145gm LIP: 35gm 1210ml (m)TPN AA 42GM DEX: 432gm 2070ml (n)TPN AA 50gm DEX: 130gm 2500ml (o)TPN AA 55gm DEX:180gm 1000ml (p)TPN AA 70gm DEX:290gm 2100ml (q)TPN AA 70gm DEX:290gm 2500ml (r)TPN AA 80gm DEX:200gm 1900ml (s)TPN AA 80gm DEX:200gm LIP:38gm 1900ml (t)TPN AA 30gm; DEX 82gm; IN 890ml (u)TPN AA 30gm; DEX 82gm; LIP 18gm in 890 ml
TPN (a)115gm/AA, 215gm/DEX, 25gm/LIP 1150ml (b)90gm/AA, 215gm/DEX, 25gm/LIP 1150ml (c)TPN AA: 100gm DEX: 105gm 2700ml (d) TPN AA: 100gm DEX: 105gm LIP: 45gm 2700ml (e)TPN: AA100gm; DEX185gm; LIP50gm in 1500ml (f)TPN: AA 150gm; DEX 220gm; LIP 45gm in 2400ml (g)TPN: AA 60gm; DEX 200gm; LIP 30gm in 1500ml
TPN (a)95gm/AA,385/DEX, 50gm/LIP 1800ml (b)TPN AA:100gm DEX:250gm LIP:50gm 2400ml (c)TPN: AA 80gm; DEX 320gm; LIP 50gm in 2300ml
Vancomycin (a)1.25gm in NS 250ml (b)1.5gm in NS 300ml (c)1000mg in NS 200ml (d)2gm in 400ml NS (e)900mg in NS 180ml (f)500mg NS 100ml (g)750mg NS 150ml
Vancomycin (a)700mg NS 140ml (b)1000mg in NS 200ml
Vitamin K (Phytonadione) 2.5mg(0.25ml) Syringe
Thiamine Hydrochloride 200mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection
Thiamine Hydrochloride 3000mg/30mL (100mg/mL), Riboflavin 30mg/30mL (1mg/mL) Injection
Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle
Humatrix Microclysmic Gel 8 oz bottle
Metoprolol Succinate Extended-Release 50 mg Tablets
Bupropion Hydrochloride 75 mg Tablets
Abelcet (Amphotericin B Lipid Complex) Injection 5 mg/ml 100 mg vial
New & Improved Blue Gel Anesthetic 1oz bottle
Maximum Zone2 Topical Analgesic 1oz bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/21/2023
Class I Recall
Hand Sanitizer (nanoMaterials Discovery Corporation)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/15/2023
Class II Recall
Ohm Hand Sanitizer (alcohol (ethanol) 70 %
Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80%
Posaconazole Delayed-Release 100 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/13/2023
Class I Recall
PrimeZEN Black 6000 male enhancement capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/08/2023
Class I Recall
Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%)
First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets (Adventure Marine 150, Adventure First Aid, Easy Care First Aid, CVS First Aid Home)
Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) or; b) 16 fl. oz. (473 mL)
Class II Recall
Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.); b) 16 fl. oz. (473 mL) ; c) Rubbing Alcohol 10 fl. oz. (296 mL)
Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.)
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.)
Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.)
Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL); b) 16 FL OZ (473 mL); c) 1 Gallon (128 FL OZ) 3785.41 mL
Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL
Diltiazem Hydrochloride Extended-Release 360 mg Capsules
Conzerol zero molluscum contagiosum Topical Cream
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/02/2023
Class I Recall
Artificial Tears Lubricant Eye Drops
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/01/2023
Class I Recall
Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton
Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottle and b) 200-count bottles
Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G
Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules
Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules
TIROSINT®-SOL (levothyroxine sodium)
Class II Recall
Allopurinol Tablets USP, 100 mg, 100-count bottle
Metoprolol Succinate Extended-Release Tablets, USP 25 mg
Metoprolol Succinate Extended-Release Tablets, USP 50 mg
Metoprolol Succinate Extended-Release Tablets, USP 50 mg
0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch
S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch
Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton
5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic
Acetylcysteine 10% Ophthalmic Solution
Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Apomorphine HCL 2MG/ML (10ML vial) Injectable
Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable
Buprenorphine HCL 0.9 MG/ML (25ML vial) Injectable
Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable
Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable
Cholecalciferol (Vitamin D3) 100,000U/ML Injectable
Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation
Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% Oph solution
DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE; DEXAMETHASONE-PF- 0.1% (1ML DROPPER) OPH SOLUTION
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) Injectable
Dutasteride 0.1% (1.5ML VIAL) Injectable
Edetate Calcium Disodium 400MG/ML (30ML vial) Injectable
EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution
Estradiol 0.05% OPH Solution, Rx Only
ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST CYP -SS OIL- 2MG/25MG/ML (1ML VIAL) INJECTABLE; ESTRADIOL CYP-CS OIL- 5MG/ML (1.25ML VIAL) INJECTABLE; ESTRADIOL CYP-GS OIL- 5MG/ML (1ML VIAL) INJECTABLE ESTRADIOL CYP-SS OIL- 5MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP-SS OIL- 5MG/ML (1ML VIAL) INJECTABLE
Ethyl Alcohol 95% (5ML vial) Injectable
FLURBIPROFEN -CORN OIL- 0.04% (3ML DROPTAINER) OPH SOLUTION
GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION
GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED-PF- 200MG/ML (2ML VIAL) INJECTABLE
GLYCERIN 72% (W/V) (15ML VIAL) INJECTABLE
GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable
GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 48.7%(W/V)/0.67%/0.00067% (10ML VIAL) INJECTABLE
HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION
Hydroxocobalamin 25MG/ML (2ML vial) Injectable
HYDROXOCOBALAMIN-PF- 1MG/ML (1ML VIAL) INJECTABLE
KETAMINE 50MG/ML (10ML VIAL) INJECTABLE
LEVEMIR-STS- 100U/ML (1ML VIAL) INJECTABLE
LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE
MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (5ML VIAL) INJECTABLE
METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/METHYLCOBAL 15MG/50MG/100MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/RIBOFLA/NIACINAMIDE/PYRIDOX/ASCORBIC ACID 15.625MG/31.25MG/31.25MG/6.25MG/62.5MG/6.25MG/62.5MG/ML (1ML VIAL) INJECTABLE
METHOTREXATE INTRAVITREAL (1ML VIAL) 4MG/ML (400MCG/0.1ML) INJECTABLE
METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 3MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (0.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 12.5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 25MG/ML (0.5ML VIAL) INJECTABLE
Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylcobalamin 5MG/ML (1ML vial) INJECTABLE
Minoxidil 0.75% (1.5ML vial) Injectable
MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIAL) OPH SOLUTION
MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH SOLUTION; MITOMYCIN 0.4MG/ML (4ML VIAL) OPH SOLUTION
NADH 10MG/ML (10ML VIAL) INJECTABLE
PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/1MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/2MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/3MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/5MG/ML (1ML VIAL) INJECTABLE
PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 15MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 30MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE
PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT (1ML) 10MCG/30MG/2MG/ML INJECTABLE PE1/PAPAV/PHENT 10MCG/18MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 11.8MCG/18MG/0.6MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 12.2MCG/19.29MG/1.22MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 12.5MCG/24MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 40MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/18MG/0.6MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.8MCG/17.44MG/0.64MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.9MCG/17.64MG/0.59MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/15MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 70MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 8.3MCG/25MG/0.83MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 80MCG/30MG/3MG (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/12MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 40MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 50MCG/30MG/2MG/0.1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 60MCG/30MG/4MG/0.15MG/ML (1ML VIAL) INJECTABLE
PHENOL 10% (10ML VIAL) INJECTABLE
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE
POLIDOCANOL 50MG/ML (5%) (30ML VIAL) INJECTABLE
POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION
PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE
PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 20MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 22.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 23MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 30MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 40MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 44.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 45MCG/ML (3ML VIAL) INJECTABLE PROSTAGLANDIN E1 50MCG/ML (1ML VIAL) INJECTION PROSTAGLANDIN E1 60MCG/ML (1ML VIAL) INJECTABLE
SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION
SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 4MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 5.4MG/ML (0.5ML VIAL) INJECTABLE
TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02% (10ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (15ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (5ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.03% (10ML DROPPER) OPHTHALMIC
TESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/0.5MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP/PROP(80/20)-GS OIL- 200MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-CS OIL-PF- 80MG/ML (0.7ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 100MG/ML (1.2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 150MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 150MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (2.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 20MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 20MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 300MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (2.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 75MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 75MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 80MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 80MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL-PF- 75MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-OLIVE OIL- 50MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 125MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 200MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 50MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL-PF- 80MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE ENAN-GS OIL-PF- 300MG/ML (0.4ML VIAL) INJECTABLE TESTOSTERONE-PF- 50MG/ML (5%) (1ML DROPTAINERS) OPHTHALMIC
THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/METHYLFOLATE/METHYLCOBAL 10MG/2.5MG/25MG/5MG/5MG/10MG/10MG/ML (1ML VIAL) INJECTABLE THIAMINE/RIBOFLAVIN/NIACINAMIDE/DEXPANTHENOL/PYRIDOXINE 50MG/1MG/100MG/3MG/2MG/ML (30ML VIAL) INJECTABLE
TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION
VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML (3ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED-STS- 50MG/ML OPH SOLUTION VANCOMYCIN-STS- 25MG/ML (2ML DROPTAINER) OPH SOLUTION
VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE
VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION
Allopurinol Tablets 100mg, USP, 90-count bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/30/2023
Class II Recall:
Hair & Scalp Spray SPF 30
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/25/2023
Class I Recall:
Daptomycin for Injection 350 mg/vial 1 Single-dose vial
Class II Recall:
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile
Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile
Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle
Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle
ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube
Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton)
GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle
Ketorolac Tromethamine Ophthalmic Solution, 0.5%
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle
Lidocaine Hydrochloride Jelly USP, 2%
Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.)
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle
PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube
Timolol Maleate Ophthalmic Solution, USP, 0.5%
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle
Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11)
Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle
Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles
Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL)
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL)
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL)
SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), and c) 16.9 oz (500 ml)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
1/18/2023
Class II Recall:
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL
Rifampin Capsules USP, 300 mg, 30-count bottle
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton
BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials
Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only
Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials
Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials
Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials
Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials.
QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials
QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials
TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials
TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials
Rifampin Capsules, 300 mg, 30 count blister card, Rx only
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
1/11/2023
Class II Recall
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags
Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compound
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/28/2022
Quinapril Tablets USP, 20 mg (90 pack)
Quinapril Tablets USP, 40 mg (90 pack)
Oxcarbazepine Tablets 600mg
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets
Vancomycin HCl Injection, USP, 1.5g/vial single dose fliptop vial
Easy Care first aid Afterburn cream 0.9 g single use packets
Adventure Marine 150 First aid kit
Adventure First Aid 1.0
Adventure First Aid 1.5
Easy Care First Aid 25 person 2009 ANSI
Easy Care First Aid 10 person 2009 ANSI
Easy Care First Aid Class A ANSI 25 person
Easy Care First Aid 25 Person 2009 ANSI
CVS First Aid Home Kit
Easy Care First Aid 10 person 2009 ANSI
Daptomycin for injection 500 mg/vial
Daptomycin for injection 350 mg/vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/21/2022
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL)
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL)
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium
FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free
Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles
Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles
ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles
Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/14/2022
Sodium Chloride 0.9% Injection USP 1000 ml
Sodium Chloride 0.9% Injection USP 100 ml
Desmopressin Acetate 0.2 mg Tablet
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/07/2022
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr)
Desmopressin Acetate Tablets 0.2mg
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,)
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/30/2022
Pantoprazole Sodium for Delayed-Release Oral Suspension 40 mg Sodium
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/23/2022
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v
Phenoxybenzamine Hydrochloride Capsules, USP 10mg
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/16/2022
Octreotide Acetate Injection 500 mcg/mL 10 x 1 mL Single-Dose Unit-of-Use Syringes
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/09/2022
ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers
ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers
AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers
BRILLIANT BLUE G, 0.04% Solution, 2 mL vials
CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe
CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe
CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles
GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer
LAURETH-9 INJ 2% Solution, 30 ML vial
LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes
LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe
MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial
METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials
MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe
MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes
PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG /2.5MG/ 50MCG SOLUTION, 5 mL vials
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial
PAPAVERINE / PHENTOLAMINE INJECTION 150MG /5MG/ VIAL SOLUTION, 10 mL vials
PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial
PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial
PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers
PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials
SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials
SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers
TALC, STERILE POWDER, 5 GM vial
VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes
VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles
Adam’s Polishes Hand Sanitizer
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/02/2022
Atenolol Tablets USP 25 mg
Sodium Bicarbonate 8.4% Injection USP 50 mEq/50 mL(1 mEq/mL)
Sodium Bicarbonate 8.4% Injection USP 50 mEq/50 mL(1 mEq/mL)
Fondaparinux Sodium Injection USP 7.5 mg per 0.6 mL
Pyridostigmine Bromide Oral Solution USP 60 mg/5 mL
Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
Proton Armor Anti-Microbial Alcohol-Free Foaming Hand Sanitizer
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/26/2022
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottle
Rifampin Capsules, USP, 150 mg, 30-count bottle
Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle, b) 60-count bottle, c) 100-count bottle
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/25/2022
Octreotide Acetate Injection 500 mcg/mL 10x1 mL Single dose unit-of-use Syringe
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/24/2022
Quinapril and hydrochlorothiazide tablets, USP, 20 mg/12.5 mg, 90s HDPE bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/19/2022
Skincell Mole & Skin Corrector Serum
Skincell Mole & Skin Corrector Serum
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/13/2022
Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/12/2022
Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles
Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/05/2022
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified 25 mg
Budesonide Inhalation Suspension 0.25mg/2mL
Rifampin Capsules USP 150 mg
Rifampin Capsules USP 300 mg
Ampicillin for Injection USP 2 grams/vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/21/2022
CVS Health, Magnesium Citrate Saline Laxative, Oral Solution
Equate Magnesium Citrate, Saline Laxative, (1.745g/fl oz) 10 FL OZ (296mL)
Equaline magnesium citrate Saline Laxative, oral solution
Kroger, Magnesium Citrate Saline Laxative, Oral Solution
Meijer, magnesium citrate Saline Laxative, Oral Solution
P, magnesium citrate Saline Laxative, Oral Solution
Rexall, Magnesium Citrate Saline Laxative, Oral Solution
Swan, Citroma Magnesium Citrate, Saline Laxative, Oral Solution
Topcare Health, Magnesium Citrate, Saline Laxative, Oral Solution
Walgreens, Dye-Free, Magnesium Citrate, Saline Laxative, Oral Solution
Walgreens, Dye-Free, Magnesium Citrate, Saline Laxative, Oral Solution
Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL)
Magnesium Citrate Saline Laxative, Oral Solution
Magnesium Citrate Saline Laxative, Oral Solution
Magnesium Citrate Saline Laxative, Oral Solution
L-Carnitine 500 mg/mL Injectable, 10 ML vial
MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial
Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe
TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial
TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials
TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial
TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial
TRI-MIX 30/1/10 Injectable, 10 ML vial
TRI-MIX 30/1/20 Injectable, 5 ML vial
TRI-MIX 30/1/40 Injectable, 10 ML vial
TRI-MIX 30/1/60 Injectable, 5 ML vial
TRI-MIX 30/2/20 Injectable, 10 ML vial
TRI-MIX 30/2/40 Injectable, 10 ML vial
TRI-MIX 50/2.5/25 Injectable, 2 ML vial
QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 15 mg Synergy Hand Sanitizer
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution
Lisinopril Tablets USP, 10 mg, 1000-count bottles
Triamcinolone Acetonide cream, 0.1%, 80 g tube
Lisinopril 10 mg tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/14/2022
Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Milk of Magnesia USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Milk of Magnesia USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Calcium Carbonate Oral Suspension, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only
Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Guaifenesin and Dextromethorphan 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Guaifenesin and Dextromethorphan 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only
Correctdose Children's Allergy Relief (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses
Correctdose Children's Pain Relief & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses
Correctdose Children's Cough & Chest Congestion DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/07/2022
Triamcinolone Acetonide 0.1% Cream, 80 g tube
Neomycin Sulfate 500 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/31/2022
Divalproex Sodium 250 mg Extended Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/24/2022
Rifampin 150 mg Capsules
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes
Prednisolone 15 mg per 5 mL Oral Solution, 240 ml bottle
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only
Ketorolac Tromethamine Injection, 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton
PF-0.125% Bupivacaine HCl Injection, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case
PF-Labetalol HCl Injection, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/22/2022
PropofolInjectable Emulsion, 100 mL Single Patient Use Glass Fliptop Vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/17/2022
Telmisartan and Hydrochlorothiazide 80 mg/25 mg Tablets
Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg Tablets
Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g
Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each
Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile
Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box
Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box
Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box
Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box)
Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box
Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box
A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar
Dakin's Solution, sodium hypochlorite 0.125%, quarter strength
Dakin's Solution, sodium hypochlorite 0.25%, half strength
Dakin's Solution, sodium hypochlorite 0.5% full strength
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral
Inhalation Only, 30 vials per box
Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton
Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box
Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box
Lorazepam 2mg/mL Injection, 1 mL vial, 25 vials per carton
Ativan Injection (lorazepam injection), 2mg/mL, 1 mL vial, 25 vials per carton
Lorazepam 2mg/mL Injection, 1 mL vial, 25 vial per carton
Lorazepam 4mg/mL Injection, 1 mL vial, 25 vial per carton
Prednisone 20 mg Tablets
Fentanyl Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags
Fentanyl Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/10/2022
Naftifine Hydrochloride 1% Gel
Matzim LA (Diltiazem Hydrochloride) 180 mg Extended-Release Tablets
Matzim LA (Diltiazem Hydrochloride) 240 mg Extended-Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/04/2022
Milk of Magnesia 2400 mg / 30 mL Oral Suspension
Milk of Magnesia 2400 mg / 10 mL Oral Suspension
Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL OralSuspension
Magnesium Hydroxide 2400 mg / Aluminum Hydroxide 2400 mg / Simethicone 240 mg per 30 mL Oral Suspension
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/03/2022
Nifedipine WSP 0.2% Ointment, 60 gram tubes (Compound)
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100)
Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL)
Divalproex Sodium 500 mg Delayed-Release Tablets
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose
Lansoprazole 15 mg Delayed-Release Orally Disintegrating Tablets
Lansoprazole 30 mg Delayed-Release Orally Disintegrating Tablets
Irbesartan 150 mg Tablets
Irbesartan 75 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/27/2022
Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags
Atropine Sulfate Injection, 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case
Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Epinephrine Injection, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Epinephrine Injection 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Fentanyl Citrate in 0.9% Sodium Chloride Injection, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case
Glycopyrrolate Injection, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Glycopyrrolate Injection, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Hydromorphone HCl Injection, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Hydromorphone HCl Injection, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per cas
Hydromorphone HCl Injection, 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Hydromorphone HCl Injection, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Ketamine HCl Injection, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Ketamine HCl Injection, 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Ketamine HCl Injection, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Labetalol HCl Injection, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Lidocaine HCl Injection, 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Lidocaine HCl Injection, 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Morphine Sulfate Injection, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Morphine Sulfate Injection, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Morphine Sulfate Injection, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Morphine Sulfate Injection, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case
Neostigmine Methylsulfate Injection, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Neostigmine Methylsulfate Injection, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Neostigmine Methylsulfate Injection, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case
Phenylephrine HCl Injection, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Phenylephrine HCl Injection, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Phenylephrine HCl Injection, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL
Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case
Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case
Aripiprazole 20 mg Tablets
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/26/2022
Best Choice 10oz Lemon Magnesium Citrate
Best Choice 10oz Cherry Citrate
Best Choice 10oz Grape Citrate
Care One 10oz Lemon Magnesium Citrate
Care One 10oz Cherry Citrate
Cariba 10oz Lemon Magnesium Citrate
Cruz Blanc 10oz Lemon Magnesium Citrate
CVS 10oz Lemon Magnesium Citrate
CVS 10oz Lemon Magnesium Citrate
CVS 10oz Cherry Citrate
CVS 10oz Clr Grape Citrate
Discount Drug Mart 10oz Lemon Magnesium Citrate
Equaline 10oz Lemon Magnesium Citrate
Equaline 10oz Cherry Citrate
Equate 10oz Lemon Magnesium Citrate Syrup
Equate 10oz Cherry Citrate Syrup
Equate 10oz Grape Magnesium Citrate Syrup
Exchange Select 10oz Lemon Magnesium Citrate
Family Wellness 10oz Lemon Citrate
Family Wellness 10oz Cherry Citrate
Good Sense 10oz Lemon Magnesium Citrate
Good Sense 10oz Cherry Citrate
Harris Teeter 10oz Lemon Magnesium Citrate
Heb 10oz Lemon Mag Citrate
Heb 10oz Cherry Citrate
Heb 10oz Grape Magnesium Citrate
Health Mart 10oz Lemon Magnesium Citrate
Health Mart 10oz Cherry Citrate
Kroger 10oz Lemon Magnesium Citrate
Kroger 10oz Grape Citrate
Leader 10oz Lemon Magnesium Citrate
Leader 10oz Cherry Citrate
Leader 10oz Grape Magnesium Citrate
Major 10oz Lemon Magnesium Citrate
Meijer 10oz Lemon Magnesium Citrate
Meijer 10oz Cherry Citrate
Premier Value 10oz Low Sodium Lemon Citrate
Premier Value 10oz Cherry Citrate
Publix 10oz Lemon Magnesium Citrate
Publix 10oz Cherry Citrate
Quality Choice 10oz Lemon Magnesium Citrate
Quality Choice 10oz Cherry Citrate
Rexall 10oz Lemon Magnesium Citrate
Rexall 10oz Cherry Citrate
Rexall 10oz Grape Magnesium Citrate
Rite Aid 10oz Lemon Citrate
Rite Aid 10oz Cherry Citrate
Signature Care 10oz Lemon Magnesium Citrate
Signature Care 10oz Cherry Citrate
Sound Body 10oz Lemon Magnesium Citrate
Sunmark 10oz Lemon Magnesium Citrate
Sunmark 10oz Cherry Citrate
Swan 10oz Lemon Magnesium Citrate
Swan 10oz Cherry Citrate
Topcare 10oz Lemon Magnesium Citrate
Topcare 10oz Cherry Citrate
Up&Up 10oz Lemon Magnesium Citrate
Up&Up 10oz Lemon Magnesium Citrate
Walgreens 10oz Lemon Magnesium Citrate
Walgreens 10oz Cherry Citrate
Walgreens 10oz Grape Magnesium Citrate
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/20/2022
Morphine Sulfate 30 mg Extended-Release Tablets
Morphine Sulfate 60 mg Extended-Release Tablets;
Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding
Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding
Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding
BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding
Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding
Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding
Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding
Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding
Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding
Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding
Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding
Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding
Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding
Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding
Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding
Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding
PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding
Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding
Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding
Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor Made Compounding
Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding
Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperature, Tailor Made Compounding
Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room temperature, Tailor Made Compounding
Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding
Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding
Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding
Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding
Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding
Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding
Vitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding
Testosterone Cypionate 200mg/mL Injection, CIII
Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton
Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/15/2022
Best Choice 10oz Lemon Magnesium Citrate
Care One 10oz Lemon Magnesium Citrate
Cariba 10oz Lemon Magnesium Citrate
Cruz Blanc 10oz Lemon Magnesium Citrate
CVS 10oz Lemon Magnesium Citrate
CVS 10oz Lemon Magnesium Citrate
Discount Drug Mart 10oz Lemon Magnesium Citrate
Equaline 10oz Lemon Magnesium Citrate
Equate 10oz Lemon Magnesium Citrate Srp
Exchange Select 10oz Lemon Magnesium Citrate
Family Wellness 10oz Lemon Citrate
Good Sense 10oz Lemon Magnesium Citrate
Harris Teeter 10oz Lemon Magnesium Citrate
Heb 10oz Lemon Magnesium Citrate
Health Mart 10oz Lemon Magnesium Citrate
Kroger 10oz Lemon Magnesium Citrate
Leader 10oz Lemon Magnesium Citrate
Major 10oz Lemon Magnesium Citrate
Meijer 10oz Lemon Magnesium Citrate
Premier Value 10oz Low Sodium Lemon Citrate
Publix 10oz Lemon Magnesium Citrate
Quality Choice 10oz Lemon Mag Citrate
Rexall 10oz Lemon Magnesium Citrate
Rite Aid 10oz Lemon Citrate
Signature Care 10oz Lemon Magnesium Citrate
Sound Body 10oz Lemon Magnesium Citrate
Sunmark 10oz Lemon Magnesium Citrate
Swan 10oz Lemon Magnesium Citrate
Topcare 10oz Lemon Magnesium Citrate
Up&Up 10oz Lemon Magnesium Citrate
Up&Up 10oz Lemon Magnesium Citrate
Walgreens 10oz Lemon Magnesium Citrate
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/13/2022
Propofol Injectable Emulsion, 100 mL Single Patient Use Glass Fliptop Vial
CVS Health Magnesium Citrate Saline Laxative, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL)
Enalapril Maleate 2.5 mg Tablets
Enalapril Maleate 5 mg Tablets
Enalapril Maleate 10 mg Tablets
Enalapril Maleate 20 mg Tablets
Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1
Doxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension bottles, Peppermint, Qty: 1
Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1
Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box
Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1
Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1
Testosterone Cypionate 200mg/ml Injection, One Single-dose vial
Eszopiclone 1 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/06/2022
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL Prefilled Pen
Tegsedi (inotersen) Injection 284 mg/1.5 mL, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution)
Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes
SnoreStop NasoSpray, 0.3 FL OZ (9 mL)
Losartan Potassium 25 mg Tablets
Losartan Potassium 50 mg Tablets
Losartan Potassium 100 mg Tablets
Fluticasone Propionate 50 mcg Nasal Spray, 16 g net fill weight per amber glass bottle
Losartan potassium & Hydrochlorothiazide 100 mg/25 mg Tablets
Desmopressin Acetate 0.2 mg Tablets
Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL (2 fl. oz.) bottle
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/29/2022
Morphine Sulfate 30 mg Extended-Release Tablets
Morphine Sulfate 60 mg Extended-Release Tablets
Clonazepam 0.125mg Orally Disintegrating Tablets
Testosterone Cypionate Injection, 200 mg/mL, 1 mL Single-dose vial per carton
Testosterone Cypionate Injection, 200 mg/mL, 1 mL Single-dose vial per carton
Clonidine 0.3 mg/day Transdermal System, 4 Patches
Tretinoin 10 mg Capsules
70% Isopropyl Alcohol First aid antiseptic, 4 FL OZ (118 mL) bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/22/2022
Medroxyprogesterone Acetate 150 mg/mL Injectable Suspension, 1 mL Prefilled Syringe
Medroxyprogesterone Acetate 150 mg/mL Injectable Suspension, 1 mL Prefilled Syringe
Medroxyprogesterone Acetate 150 mg/mL Injectable Suspension, 1 mL Prefilled Syringe
Medroxyprogesterone Acetate 150 mg/mL Injectable Suspension, 1 mL Prefilled Syringe
Medroxyprogesterone Acetate 150 mg/mL Injectable Suspension, 25 x 1 mL Single-Dose Vial
Zileuton 600 mg Extended-Release Tablets
CVS Health: Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor 10 FL OZ (296 mL)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/15/2022
EPI-PEN 2-PAK (epinephrine injection), Single-Dose Auto-Injectors 0.3 mg
Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL)
TobraDex (tobramycin and dexamethasone), 3.5 gm Ophthalmic Ointment
Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz
Azithromycin for Injection Vial, 500 mg per vial
Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct)
Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL
Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL
Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL
Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL
Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL)
Lidocaine Patch, 5%, 30-count box
Olanzapine single dose vial Lyophilized, 10 mg
Arzol (Silver Nitrate Applicator), (Silver Nitrate 75%, Potassium Nitrate 25%)
Sumatriptan Injection, USP, 6mg/0.5 mL, packaged in a box of 5 x 0.5 mL single-dose vials
Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL)
Ampicillin for Injection, 1 g per vial
Epidural Tray, Nerve Block Single shot
Dihydroergotamine Mesylate, Injection, 1mg/mL, packaged in box of 5 x 1 mL ampules
EPI-Pen Jr, 2-PAK, (epinephrine injection) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton
Epinephrine Injection, Single-Dose Auto-Injectors 0.3 mg, packaged in 2 count carton
Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton
Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), packaged in a kit
Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit
GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit
Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile Unit-Dose Vials
Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials
Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose vials
Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple dose vial
Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 metered inhalations
Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations
Amoxicillin 500 mg Capsules
Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle
Aprepitant 40 mg Capsule, 1 capsule per unit dose package
Betamethasone Dipropionate 0.05% Cream, 45 grams tube
Ciprofloxacin Ophthalmic 0.3% Solution, 10 mL bottle
Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine)
Sterile Water for Injection USP, 2000 mL
Doxycycline 100 mg Capsules
BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle
BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle
Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle
Miostat (Carbachol Intraocular Solution) 0.01%, 1.5 mL
Meclizine Hydrochloride 25 mg Tablets, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton
Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each containing 1 mg per vial)
Naltrexone Hydrochloride 50 mg Tablets
Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box (25 x 2.5 mL sterile unit-dose vials)
Clomiphene Citrate 50 mg Tablets
Olanzapine 10 mg Orally Disintegrating Tablets, 30-count box unit dose tablets (3 blister cards each containing 10 tablets)
Lidocaine Patch 5%, 30-count carton
Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle
Hydrocortisone Ointment, 2.5%, NET WT 28.35 g (1 oz) tube
Hydroxyzine Pamoate 50 mg Capsules
Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes
Metronidazole 0.75% Vaginal Gel with 5 applicators
Nitrostat (Nitroglycerin Sublingual) 0.4 mg/tablet
Xylocaine - MPF (lidocaine HCl and epinephrine injection), 1%, 300 mg/30 mL, single dose vial
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial Diluent for Glucagon, 1ml syringe
Xylocaine + Epinephrine, multi dose vial 1%
Xylocaine + Epinephrine, multi dose vial 2%, 20 mL
Doxycycline Hyclate 100 mg Tablets, 50-count carton (10 tablets each blister pack x 5)
Ibuprofen 400 mg Tablets
Metronidazole 250 mg Tablets
Promethazine HCl 25 mg Tablets
Sodium Bicarbonate 600 mg Tablets
Sulfamethoxazole and Trimethoprim 800mg/160mg Tablets
Medroxyprogesterone Acetate 150 mg/mL injectable suspension, 1 mL single dose vial
Methylprednsolone Acetate 40 mg/mL Injectable Suspension
Methylprednsolone Acetate 200 mg/5 mL (40 mg/mL) Injectable Suspension, 5 mL Multiple Dose Vial
Methylprednsolone Acetate 400 mg/10 mL (40 mg/mL) Injectable Suspension, 10 mL Multiple Dose Vial
Methylprednsolone Acetatee 400 mg/5 mL (80 mg/mL) Injectable Suspension, 5 mL Multiple Dose Vial
Ketoconazole Cream, 2%, Net Wt 60 grams tube
Clonidine Hydrochloride 0.1 mg Tablets
Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations
Lidocaine Patch 5%, 30-count box
Medroxyprogesterone acetate 150 mg/mL injectable suspension
Methylprednsolone Acetate 40 mg/mL Injectable Suspension
Methylprednsolone Acetate 200mg/5mL (40 mg/mL) Injectable Suspension, 5 mL multi-dose vial
Methylprednsolone Acetate 400 mg/10 mL (40 mg/mL) Injectable Suspension, 10 mL multi-dose vial
Methylprednsolone Acetate 80 mg/mL Injectable Suspension
Methylprednisolone Acetate 400 mg/5mL (80 mg/mL) Injectable Suspension, 5 mL multi-dose vials
Mupirocin 2% Ointment, 22 grams tube
Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered inhalations
Propofol Injectable Emulsion, 200 mg/ 20 mL (10 mg/mL)
Propofol Injectable Emulsion, 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials
Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial
Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box
Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box
Recothrom Thrombin Topical (Recombinant), 5,000 units, packaged in a box containing a 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe
Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) transdermal Systems Multipack
E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle
E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box\
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution)
Kinevac (Sincalide for Injection) 5mcg per vial
Levofloxacin 500 mg Tablets
Celestone Soluspan (betamethasone sodium phosphate and betametasone acetate injectable suspension 6 mg/mL, 30 mg/5mL, multidose vial
Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalations
Duraclon (clonidine HCl injection, 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial
Loperamide Hydrochloride 2 mg Capsules
Prazosin Hydrochloride 1 mg Capsules
Labetalol Hydrochloride 100 mg Tablets
Bupivacaine Hydrochloride 0.5% (5mg/mL), 25 vials x 50 mL per box
Depo-Medrol (methylprednisolone acetate) 40 mg/mL injectable suspension, 1 mL single-dose vial
Depo-Medrol (methylprednisolone acetate) 80mg/mL injectable suspension
Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack)
Thrombin JMI, Vial 5,000IU 2/diluent, kit
Verapamil HCL, Ampule, 2.5 mg/ML 2ML (5/pack)
Diphenhydramine HCl 5 mg/10 mL Oral solution
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube
Ondansetron HCL 8 mg filmcoated Tablets
Pantoprazole Sodium 40 mg/vial for Injection, 10 single-dose vials
Prednisolone Acetate 1% Ophthalmic Suspension, 5 mL bottle
Triamcinolone Acetonide 0.1% Cream ,15 grams tube
Polymyxin B Sulfate and Trimethoprim 0.1% Ophthalmic Solution, sterile, 10 mL bottle
Tropicamide 1% Ophthalmic Solution, 3 mL bottle
Pilocarpine HCL 2% Ophthalmic Solution, 15 mL
Metoprolol 50 mg Tablets
Sumatriptan Succinate 100 mg Tablets, 9 (1 x 9) Unit-of- use tablets box
Geodon for injection (ziprasidone mesylate), 20 mg/mL, 1 mL single dose vial
Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle
Ofloxacin Otic Solution 0.3%, 5 mL bottle
Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial
Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial
Cefazolin 1 Gram for injection and Dextrose Injection 50 ML duplex container
Cefazolin 2 gram for injection and Dextrose Injection 50 mL duplex container
Intralipid (I.V. Fat emulsion), 20%, 250 mL bag
Intralipid (I.V. Fat emulsion), 20%, 100 mL bag
Biopsy and Aspiration Tray Bone Marrow Illinois 11GX4 (10/cs) Rx CRFPED Lidocaine Hydrochloride USP, 1%, 5mL
Paracentesis/Thoracentises Tray (10/cs)
Ethanol for Injection 95%, 67 mL Multi-Dose vial
B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic
Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton
Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles
Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles
Earache Drops, 0.33 FL OZ (10 mL) bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/14/2022
Artri King Reforzado Con Ortiga Y Omega 3
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/09/2022
SnoreStop NasoSpray, packaged in 0.3 FL OZ (9ml) bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/08/2022
Losartan Potassium & HCTZ 100 mg/12.5 mg Tablets
8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton
Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton
Epinephrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton
Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton
Losartan Potassium 25 mg Tablets
Losartan Potassium 50 mg Tablets
Losartan Potassium 100 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/01/2022
Ukoniq (umbralisib)
Losartan HCTZ 100 mg/25 mg Tablets
Losartan HCTZ 100 mg/12.5 mg Tablets
Losartan HCTZ 50mg /12.5 mg Tablets
Losartan Potassium & HCTZ 5 0mg/12.5 mg Tablets
Losartan Potassium & HCTZ 50 mg/12.5 mg Tablets
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches
Losartan Potassium & HCTZ 100 mg/12.5 mg Tablets
Losartan Potassium & HCTZ 50 mg/12.5 mg Tablets
Losartan Potassium & HCTZ 100 mg/25 mg Tablets
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial
RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL
SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial
Diluent for Reconstitution Multi-Dose 10 mL vial
Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial
Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial
Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial
Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial
Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial
T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL
T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL
Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial
Testosterone Cypionate 200 mg/mL in Sesame Oil
Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL Multi-Dose 30 mL vial
Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, Multi-Dose 10 mL vialSte
Vitamin D3 (50,000 IU/mL)Multi-Dose 30 mL vial
Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial
Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial
Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial
AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial
Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL
Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial
Cyanocobalamin 2 mg/mL, Multi-Dose 10 mL vial
Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial
Dexpanthenol 250 mg/mL Multi-Dose 30 mL
FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial
Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial
Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL
Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial
Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial
Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial
Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial
Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL
Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL, Multi-Dose 30 mL vial
Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL Multi-Dose 30 mL vial
Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial
Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial
MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL
Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamine HCL 1.62 mg/mL Riboflavin-5-Phosphate 3.23 mg/mL Pyridoxine HCL 1.63 mg/mL Niacinamide 1.62 mg/mL Calcium Gluconate 4.07 mg/mL Ascorbic Acid 64.4 mg/mL, Single-Dose 10 mL vial
NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial
NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial
Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL Sodium Selenite 18 mcg/mL, Multi-Dose 30 mL vial
Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2 mg/mL Pyridoxine HCL (B6) 2 mg/mL Multi-Dose 30 mL vial
Ondansetron Hydrochloride, 1 mg/mL, Multi-Dose 30 mL vial
PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial
Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial
Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL 50 mg/mL Citrulline 50 mg/mL, Multi-Dose 30 mL vial
Zonisamide 100 mg Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/25/2022
Milk of Magnesia (Magnesium Hydroxide) 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton
Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box
Acetaminophen Oral Solution, 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton
Milk of Magnesia (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton
Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens
Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pen
Accupril (Quinapril HCl) 10 mg Tablets
Accupril (Quinapril HCl) 20 mg Tablets
Accupril (Quinapril HCl) 40 mg Tablets
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution with flavor pack
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/23/2022
Anagrelide 0.5 mg Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/18/2022
SyrSpend SF Suspending Base, Cherry Flavored
Esomeprazole Magnesium 20 mg Delayed-Release Capsules, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton)
Esomeprazole Magnesium 40 mg Delayed-Release Capsules, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton)
Xanax XR (alprazolam) 3 mg extended-release Tablets
MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/11/2022
Losartan Potassium 25 mg Tablets
Losartan Potassium 50 mg Tablets
Losartan Potassium 100 mg Tablets
Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg Tablets
Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg Tablets
Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg Tablets
Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle
Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube
Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube
Pantoprazole Sodium 20 mg Delayed-Release Tablets
Lansoprazole Delayed-Release 30 mg Orally Disintegrating Tablets
Losartan Potassium 25mg Tablets
Losartan Potassium 50 mg Tablets
Losartan Potassium 100 mg Tablets
Losartan Potassium - Hydrochlorothiazide 50 mg/12.5 mg Tablets
Losartan Potassium - Hydrochlorothiazide 100 mg/25 mg Tablets
Losartan Potassium - Hydrochlorothiazide 100 mg/12.5 mg Tablets
Alprazolam XR 3 mg Extended-Release Tablets
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/04/2022
NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial
Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial
Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as 3 mg or 9 mg per vial
QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atropine 0.2 mg/mL, Multi-Dose 10 mL vial
T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, Packaged as 10 ml Multi-Dose vial; 5 ml Multi-Dose vial; 2.5 ml Multi-Dose vial
Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial
AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml vial
AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose 10 ml vial
NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials
T-106, Papaverine 30 mg/mL . Phentolamine 1 mg/mL . Alprostadil 25 mcg/mL, Packaged as 10 mL Multi-Dose vial; 5 mL Multi-Dose vial
T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL. Packaged as 10 mL Multi-Dose vial; 5 mL Multi-Dose vial
SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL Multi-Dose vial
SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial
SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose 10 mL vial
ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 10 mL Multi-Dose vial
ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL Multi-Dose vial
QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial
QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial
RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in 10 mL Multi-Dose vial; 2.5 mL Multi-Dose vial
RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial
BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial
FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial
PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial
PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial
PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial
T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial
Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial
Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial
Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in 10 mL Multi-Dose vial; 5 mL Multi-Dose vial
Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in 10 mL Multi-Dose vial; 5 mL Multi-Dose vial
Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial
Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial
Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial
NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in 5 g tubes; 30 g tubes
Losartan Potassium 50 mg Tablet, 30-count blister card; 60-count blister card
Losartan Potassium 50 mg Tablets
Zonisamide 25 mg Capsules
Zonisamide 50 mg Capsules
Zonisamide 100 mg Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/03/2022
SyrSpend SF 500mL and 4L
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/27/2022
Rifampin for Injection, 600 mg/vial, One Vial per carton
Diclofenac Sodium (Generic for Pennsaid) Topical Solution 1.5% w/w, 150 ml bottle
ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials
BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials
Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials
LL-37 2 mg/mL (5 mL) Injection, 5 mL vials
Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials
Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/22/2022
Accupril® (Quinapril HCl Tablets), 10 mg
Accupril® (Quinapril HCl Tablets), 20 mg
Accupril® (Quinapril HCl Tablets), 40 mg
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/20/2022
Idarubicin Hydrochloride Injection 5gm/5mL (1mg/mL), 5mL Single Dose Vial
Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle
Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube
Lansoprazole (Generic for Prevacid) 15mg Delayed-Release Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/13/2022
Symjepi (epinephrine injection) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton
Symjepi (epinephrine injection) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton
Orphenadrine Citrate 100 mg Extended-Release Tablets
Tetracaine 1% Tetracaine HCI Injection, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box
Papaverine Hydrochloride 60 mg/2mL (30 mg/mL) Injection
Phenobarbital Sodium 65mg/mL Injection
Phenobarbital Sodium 130 mg/mL Injection
Sucralfate 1g/10ml Oral Suspension
Accuretic (quinapril HCl/hydrochlorothiazide) 10 mg/12.5 mg Tablets
Accuretic (quinapril HCl/hydrochlorothiazide) 10 mg/12.5 mg Tablets
Accuretic (quinapril HCl/hydrochlorothiazide) 20 mg/12.5 mg Tablets
Accuretic (quinapril HCl/hydrochlorothiazide) 20 mg/25 mg Tablets
Quinapril and hydrochlorothiazide 20 mg/25 mg Tablets
Quinapril HCl/hydrochlorothiazide 20 mg/12.5 mg Tablets
Quinapril HCl/hydrochlorothiazide 20 mg/25 mg Tablets
Accuretic (quinapril HCl/hydrochlorothiazide) 20 mg/12.5 mg Tablets
Janumet (sitagliptin and metformin HCl) 50 mg/500 mg Tablets, Sample-Not For Sale
Travoprost 0.004% Ophthalmic Solution, 2.5 mL bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/12/2022
Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 10 mL vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/06/2022
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy
TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy
TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formula ID 115498, APS Pharmacy
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy
TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy
Glycopyrrolate 1 mg Tablets
Lansoprazole 15 mg Delayed-Release Capsules
Lansoprazole 30 mg Delayed-Release Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/30/2022
Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection
NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP,
0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag
Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag
Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag
Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag
Betamethasone Dipropionate 0.05%* Lotion (Augmented)
Clobetasol Propionate 0.05% Cream
Clobetasol Propionate 0.05% Cream (Emollient)
Clobetasol Propionate 0.05% Lotion
Clobetasol Propionate 0.05% Ointment
Clobetasol Propionate 0.05% Gel
Desonide 0.05% Ointment
Desoximetasone 0.05% Ointment, Net Wt. 100 grams tubes
Desoximetasone 0.05% Ointment
Desoximetasone 0.25% Ointment
Diclofenac Sodium 1.5% w/w Topical Solution, 5 fl. oz. (150 mL) bottle
Diclofenac Sodium 1.5% w/w Topical Solution, 5 fl. oz. (150 mL) bottles
Diflorasone Diacetate 0.05% Ointment, Net Wt 60 g tubes
Econazole Nitrate 1% Cream
Fluocinonide 0.1% Cream, 120 grams tube
Fluocinonide 0.05% Gel
Fluocinonide 0.05% Topical Solution
Gentamicin Sulfate 0.1% Cream
Gentamicin Sulfate 0.1% Ointment
Halobetasol Propionate 0.05% Ointment, Net Wt. 50 grams tube
Halobetasol Propionate 0.05% Ointment
Hydrocortisone Butyrate 0.1% Lotion, 4 fl. oz. (118 mL) bottle
Halobetasol Propionate 0.05% Ointment, Net Wt. 50 grams tube
Hydrocortisone Butyrate 0.1% Lotion
Lidocaine 4% Cream
Lidocaine 5% Ointment, Net Wt 35.44 g (1 1/4 oz) tube
Nystatin and Triamcinolone Acetonide Ointment
Triamcinolone Acetonide 0.5% Ointment, Net Wt. 15 grams tube
Triamcinolone Acetonide 0.1% Cream
Triamcinolone Acetonide 0.025% Lotion, 60 mL (60 grams) bottle
Triamcinolone Acetonide 0.1% Ointment
Clobetasol Propionate 0.05% Cream, packaged in 60 grams tube
Diflorasone Diacetate 0.05% Ointment, Net Wt 60 g tubes
Gentamicin Sulfate 0.1% Cream, packaged in 30 grams tubes
Hydrocortisone Butyrate 0.1% Lotion, 4 fl oz (118 mL) bottle
Lidocaine 4% Cream, Net Wt. 30 grams tube
Lidocaine 5% Ointment, Net Wt 35.44 g (1 1/4 Oz) tube
Diclofenac Sodium 1.5% Topical Solution, 150 mL
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/29/2022
Idarubicin Hydrochloride 5 mg/5 mL Injection Vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/24/2022
Milk of Magnesia 2400 mg/30 mL Oral Suspension, Carton containing 100 single dose cups (10 trays x 10 cups)
Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, Carton containing 100 single dose cups (10 trays x 10 cups)
Acetaminophen 650mg/20.3mL, Carton containing 100 single dose cups (10 trays x 10 cups)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/23/2022
Hydralazine HCl 10 mg Tablets
0.9% Sodium Chloride Injection USP, 250 mL Excel Container
Alprazolam 1 mg Tablets
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags
Hydromorphone HCl 1 mg/mL 250 mL bags
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags
Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials
Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag
Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/22/2022
Accuretic™ (quinapril HCl/hydrochlorothiazide) 10/12.5 mg Tablets
Accuretic™ (quinapril HCl/hydrochlorothiazide) 20/12.5 mg Tablets
Accuretic™ (quinapril HCl/hydrochlorothiazide) 20/25 mg Tablets
SYMJEPI (epinephrine) 0.15 mg/0.3 mL Injection
SYMJEPI (epinephrine) 0.3 mg/0.3 mL Injection
Orphenadrine Citrate 100 mg Extended Release (ER) Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/16/2022
Oxycodone Hydrochloride Oral Solution, (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups
Paliperidone 9 mg Extended-Release Tablets, 100 Tablets per carton (10 x 10 blister packs)
Alprazolam C-IV 1 mg Tablets
Alprazolam C-IV 2 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/10/2022
Olympia Pharmaceuticals - Compounded Injectables - NAD (Nicotinamide Adenine Dinucleotide) 500mg vial
Olympia Pharmaceuticals - Compounded Injectables - Sincalide 5 mcg vial
Olympia Pharmaceuticals - Compounded Injectables - Trimix Formula F9 10 ml vial (Papeverine 0.9mg/ml - Phentolamine 0.1mg/ml - PGE 20mcg/ml - Atropine 0.01 mg/ml)
Olympia Pharmaceuticals - Compounded Injectables - Sermorelin Acetate 9 mg
Olympia Pharmaceuticals - Compounded Injectables - Trimix T-105 5 ml vial (Papaverine 30mg/ml - Phentolamine 1mg/ml - PGE 10mcg/ml)
Olympia Pharmaceuticals - Compounded Injectables - Trimix T-105 10 ml vial (Papaverine 30mg/ml - Phentolamine 1mg/ml - PGE 10mcg/ml)
Olympia Pharmaceuticals - Compounded Injectables - Trimix SB-4 5 ml vial (Papaverine 30mg/ml - Phentolamine 3mg/ml - Alprostadil 40 mcg/ml)
Olympia Pharmaceuticals - Compounded Injectables - Trimix SB-4 10 ml vial (Papaverine 30mg/ml - Phentolamine 3mg/ml - Alprostadil 40 mcg/ml)
Olympia Pharmaceuticals - Compounded Injectables - Hydroxocobalamin 1mg/ml 30 ml vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/09/2022
70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle
Amlodipine and Olmesartan Medoxomil 10 mg /20 mg Tablets
Olanzapine 10 mg Tablets
Moxifloxacin 0.5% Ophthalmic Solution, 3 mL
Alprazolam (Generic for Xanax) 1mg Tablets
All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.
HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/07/2022
Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/03/2022
0.9% Sodium Chloride for Injection USP 250ML in Excel
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/02/2022
Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle
Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle
Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118 mL) bottles per pack
Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle
Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle
Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle
No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 mL) per bottle
Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle
Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle
Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle
No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle
Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle
Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle
Methylphenidate Hydrochloride 2.5 mg Chewable Tablets
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v
Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/23/2022
Hydromorphone HCL PF 10 mg/50 mL (0.2 mg/mL) in NaCL, 50 mL in 50 mL Syringe, Injection for IV Use Only, This is a compounded drug
Morphine Sulfate 25 mg/25 mL (1 mg/mL) in NaCl, 25 mL in 30 mL Syringe, For IV Use Only. This is a compounded drug
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle
Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER
Alprazolam 0.25 mg Tablets
Alprazolam 0.5 mg Tablets
Alprazolam 1.0 mg Tablets
Alprazolam 2.0 mg Tablets
Pyrazinamide 500 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/16/2022
Polymyxin B for Injection, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container
Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container
APAP 325 mg (Acetaminophen 325 mg) Bulk Container
Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container
Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container
Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container
Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container
APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container
APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container
Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container
Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container
Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container
Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container
Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container
Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container
Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container
Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container
APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container
Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container
Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container
Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container
Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/09/2022
Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial
Tretinoin 10 mg Capsules
Doxylamine Succinate and Pyridoxine Hydrochloride 10 mg/10 mg Delayed-Release Tablets
Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet
Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets
Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets
CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets
Extra Strength (ES) Pain Reliever (acetaminophen 500 mg) 2 tablet packets
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets)
Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) Tablets
Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) Caplets
MidNite Sleep Health (melatonin 1.5 mg) Tablets
Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets
Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets
Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets
Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets
Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets
Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet
Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet
Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet
Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet
COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets
PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets
SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets
DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets
EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets
PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets
PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets
PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets
Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets
Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets
Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets
PAPENOL (acetaminophen 500 mg), 2 tablet packets
MAGNACAL (calcium carbonate 420 mg), 2 tablet packets
CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg)
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg)
Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets
Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets
FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets
CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets
CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets
AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets
SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets
REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets
REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/02/2022
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag
Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block
Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe
Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection
Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use
Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use
Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe
Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use
Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use
Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use
Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection
Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection
MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, Single Use Syringe For Intraocular Injection
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection
PhenyLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free)
Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use
Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use
Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection
Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag
Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag
BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use
Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use
Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use
CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Otic Use with Insufflator,
CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle
Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial
Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use
LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use
Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial
Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container
Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use
Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection
Metformin Hydrochloride 750 mg Extended-Release Tablets
Pioglitazone 45 mg Tablets
Metoprolol Succinate 50 mg Extended-Release Tablets
Metoprolol Succinate 25 mg Extended-Release Tablets
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/28/2022
Polymyxin B 500,000 Units/Vial for Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/27/2022
RevitaDerm (Wound Care Gel) 1.0 ounce bottle or 3.0 ounce tube
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/26/2022
Senna Syrup (sennosides) Natural Vegetable Laxative 8.8 mg/5mL unit-dose cups
Brinzolamide 1% Ophthalmic Suspension
Physicians Care Extra Strength Pain Reliver [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg Tablets
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) Tablets
Clobetasol Propionate 0.05% Foam, 50 g can
Clobazam 2.5 mg/mL Oral Suspension, 120 mL bottles
Lexette (halobetasol propionate) 0.05% Topical Foam, 50 g canisters
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/19/2022
Semglee® (insulin glargine injection), 100 units/mL (U-100, 3mL prefilled pens
Clobetasol Propionate 0.05% Ointment, 60g tubes
Carbamazepine 200 mg Tablets
Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles
Metoprolol Tartrate 25 mg Tablets
Methylprednisolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton
Metformin 750 mg Extended Release Tablets
8.4% Sodium Bicarbonate Injection, 50 mEq/50 mL (1 mEq/mL), 50 mL vials
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/12/2022
Equaline Aller-Ease, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
GoodSense Aller.Ease, Fexofenadine Hydrochloride 60 mg 12 Hour Tablets
Amazon, Allergy, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
Basic+Care, Allergy, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
Basic+Care, Allergy, Fexofenadine Hydrochloride 60 mg 12-Hour Tablets
Berkley Jensen, Allergy Relief, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
Careone Allergy Relief, Fexofenadine Hydrochloride 180 mg Tablets
CVS Allergy Relief, Fexofenadine Hydrochloride 60 mg 12-Hour Tablets
DG/health Aller.Ease, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
Health Mart, Fexofenadine Hydrochloride 60 mg 12-Hour Tablets
Health Mart, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
H.E.B Allergy Relief, Fexofenadine Hydrochloride 60 mg 12-Hour Tablets
H.E.B Allergy Relief, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
Kroger Allergy Relief, Fexofenadine Hydrochloride 60 mg 12-Hour Tablets
Major, Fexofenadine Hydrochloride 60 mg 12-Hour Tablets
Meijer allergy relief, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
allergyrelief, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
Perrigo, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
Perrigo, Fexofenadine Hydrochloride 60 mg 12-Hour Tablets
Rite Aid, Allergy Relief, Fexofenadine Hydrochloride 60 mg 12-Hour Tablets
Rite Aid, Allergy Relief, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
TopCare Allergy Relief, Fexofenadine Hydrochloride 60 mg 12-Hour Tablets
TopCare Allergy Relief, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
Up&Up Allergy Relief, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
Wal-Fex, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
Wal-Fex, Fexofenadine Hydrochloride 60 mg 12-Hour Tablets
Amazon Basic+Care, Allergy Fexofenadine Hydrochloride 60 mg 12-Hour Tablets
Kirkland Aller-Fex, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
CVS Allergy Relief, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
GoodSense Aller.Ease, Fexofenadine Hydrochloride 180 mg 24-Hour Tablets
Pregabalin 50 mg Capsules
Pain Aid ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, Ultratab
Cefixime 400 mg Capsules
Senna Syrup 8.8mg/5mL, unit-dose cups
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/05/2022
Lidocaine Hydrochloride 4% (40 mg/mL) Topical Solution, packaged in 50 mL screw cap bottles
Veklury (remdesivir) 100 mg/vial for injection, Single-Dose Vial
Betamethasone Dipropionate 0.05% (Augmented) Lotion, 30 mL bottle, (29 grams)
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL)
Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL)
Diltiazem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection
Norepineprine 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection
Epinephrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection
Phenylepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL)
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL)
Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL
Epinephrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL)
Epinephrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL)
Epinephrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL)
Epinephrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL)
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL)
Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL)
Norepinephrine in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection
Diltiazem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL)
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL)
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL)
Morphine Sulfate, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL)
Norepinephrine, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection
Norepinephrine, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection
Norepinephrine, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection
Norepinephrine, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection
Phenylephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection
Phenylephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection
Sodium Bicarbonate in 5% Dextrose Injection
Lidocaine Hydrochloride 4% (40 mg/mL) Topical Solution, packaged in 50 mL screw cap bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/30/2021
Clobetasol Propionate 0.05% Ointment, packaged in 60 gram tubes
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/29/2021
Fexofenadine Hydrochloride 60 mg Tablets
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton
Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles
Rompe Pecho DM, 6 Fl Oz (178 mL) bottles
Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles
Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles
Penicillin V Potassium for Oral Solution, 125 mg (200,000 U) per 5 mL
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/28/2021
Metformin Hydrochloride 750 mg Extended-Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/27/2021
Nitroglycerin Lingual Spray 400 mcg per spray
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/22/2021
Lidocaine Hydrochloride 4% (40 mg/mL) Topical Solution, 50 mL glass bottles
Clindamycin and Benzoyl Peroxide 1%/5% Gel, 25 gram jars
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles
Methylcobalamin 12mg/ml injection, 1 mL vials
B-Complex, injection, 1 mL vials
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/15/2021
Vancomycin 1 gram added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag (This is a Compounded Drug, Hospital/Office Use Only)
Hydrocodone Bitartrate and Acetaminophen 10 mg/325 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/10/2021
Rompe Pecho CF
Rompe Pecho DM
Rompe Pecho EX
Rompe Pecho MAX
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/08/2021
Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only
Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only
Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/07/2021
Aluminum Potassium Sulfate Concentrated (Pf) 300 G/300 Ml
Buffered Lidocaine HCl (Pf) 1%
Buffered Lidocaine HCl / Epinephrine Solution (Pf) 1% / 1:100,000
Ceftazidime (Pf) 22.5 Mg/Ml
Cefuroxime Ophthalmic Solution (Pf) 10 Mg/Ml
Dexamethasone Phosphate (Pf) 24 Mg/Ml
Edetate Disodium (Edta) (Pf) 1.5%
Edetate Disodium (Edta) (Pf) 3%
Epinephrine / Lidocaine Hcl (Pf) 0.025% / 0.75%
Gemcitabine (Pf) 20 Mg/Ml
Glycerin, Sterile (Pf) 99%
Lidocaine Hcl / Bupivacaine Hcl / Hyaluronidase (Pf) 2% / 0.375% / 15 Units/Ml
Methacholine Challenge 5 Syringe Test Kit
Methacholine Chloride (Pf) 16 Mg/Ml
Methacholine Chloride (Pf) 4 Mg/Ml
Methacholine Chloride (Pf) 1 Mg/Ml
Methacholine Chloride (Pf) 0.25 Mg/Ml
Methacholine Chloride (Pf) 0.0625 Mg/Ml
Methotrexate (Pf) 125 Mg/5Ml
Mitomycin Irrigation (Pf) 1 Mg/Ml
Mitomycin-C (Pf) 0.4 Mg/Ml
Mitomycin-C (Pf) 0.2 Mg/Ml
Moxifloxacin HCl (Pf) 1 Mg/Ml
Mvasi 3.75Mg/0.15Ml (25 Mg/Ml)
Neostigmine Methylsulfate 1 Mg/Ml
Norepinephrine Bitartrate 8 Mg/250Ml
Phenol, Sterile (Pf) 6%
Phenylephrine / Tropicamide / Ketorolac / Ciprofloxacin (Pf) 10% / 1% / 0.125% / 0.3%
Phenylephrine HCl 0.1 Mg/Ml
Phenylephrine HCl 0.1 Mg/Ml
Phenylephrine HCl (Pf) 800 Mcg/10 Ml
Phenylephrine Hcl (Pf) 20 Mg/ 250 Ml
Phenylephrine HCl / Lidocaine Hcl (Pf) 1.5% / 1%
Phenylephrine HCl / Tropicamide 2.5% / 1%
Phenylephrine/ Cyclopentolate / Tropicamide / Ketorolac 10% / 0.25% / 0.25% / 0.125%
Phenylephrine/ Cyclopentolate / Tropicamide / Ketorolac (Pf) 2.5% / 0.25% / 0.25% / 0.125%
Benzocaine / Lidocaine / Tetracaine 20% / 8% / 4%
Cantharidin 0.7%
Cantharidin Plus 1% / 30%
Ciprofloxacin / Sulfacetamide Sodium / Amphotericin B 30Mg / 50Mg / 5Mg
Ciprofloxacin / Sulfacetamide Sodium / Amphotericin B /
Hydrocortisone 30Mg / 50Mg / 5Mg / 25Mg
Dexamethasone Iontophoresis 0.4%
Dibutyl Squarate 2%
Dibutyl Squarate 1%
Lidocaine / Tetracaine 23% / 7%
Lidocaine HCl / Epinephrine / Tetracaine Hcl (Let) 4%/0.05%/0.5%
Lidocaine HCl / Oxymetazoline 4% / 0.05%
Lidocaine HCl / Prilocaine Hcl / Tetracaine Hcl
(Profound) Dental (Raspberry Marshmallow) 10% / 10% / 4%
Lidocaine HCl / Prilocaine Hcl / Tetracaine Hcl
(Profound) Dental Gel (Mint) 10% / 10% / 4%
Lidocaine HCl / Prilocaine Hcl / Tetracaine Hcl /
Phenylephrine HCl (Profound-Pe) Dental (Raspberry Marshmallow) 10% / 10% / 4% / 2%
Lidocaine HCl / Prilocaine Hcl / Tetracaine Hcl /
Phenylephrine HCl (Profound-Pe) Dental Gel (Mint) 10% / 10% / 4% / 2%
Phenol 89%
Phenylephrine HCl / Lidocaine Hcl 1% / 4%
Phytonadione (Vitamin K) 5 Mg/Ml
Promethazine HCl 25 Mg / 1.2Ml
Tetracaine HCl 4%
Vancomycin HCl 125 Mg / 2.5Ml (50 Mg/Ml)
Lidocaine Hydrochloride Topical Solution 4% (40 mg/mL), 50mL bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/03/2021
Veklury® (remdesivir 100mg for injection)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/02/2021
Enoxaparin Sodium 40 mg/0.4 mL Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/01/2021
Diclofenac Sodium Topical Solution, 1.5 w/w, 5 fl oz (150 mL) plastic bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/24/2021
Lotrimin AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can
Lotrimin AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can
Lotrimin AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can
Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can
Lotrimin AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can
Lotrimin AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can
Lotrimin AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can
Lotrimin AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can
Lotrimin AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can
Lotrimin AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can
Flocinolone Acetonide 0.01% Topical Oil, Body Oil, packaged in 4 oz. bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/22/2021
Levetiracetam 500 mg per 5 mL Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/17/2021
Compound - Estradiol Valerate 20 mg/mL in Ethyl Oleate Injection 20 mg/mL Injection in vials
Compound - (Well'S Lipo-Lean)Inositol/Choline/B-Comp+Leucine+Carn+ Chrom+Lido 25Mg/25Mg/1.5Mg/25Mg/25Mcg/10Mg Injectable In Vials
Compound - Alprostadil 22.5Mcg/Ml 22.5Mcg/Ml Injectable
Compound - Alprostadil 22Mcg/Ml 22Mcg/Ml Injectable
Compound - Alprostadil 25Mcg/Ml 25Mcg/Ml Injectable
Compound - Alprostadil 30Mcg/Ml Inj 30Mcg/Ml Injectable
Compound - Alprostadil 32Mcg/Ml 32Mcg/Ml Injectable
Compound - Alprostadil 40Mcg/Ml Inj 40Mcg/Ml Injectable
Compound - Alprostadil 45Mcg/Ml 45Mcg/Ml Injectable
Compound - B Complex Inj Cmp-No B12, No Lidocaine Injectable
Compound - Bi-Mix Papaverine 40/Phentolamine 2 Inj Injectable
Compound - Blue Tree Lipo Extreme (/W Methylcobalamin) Injection Injectable
Compound - Cjc-1295 4Mg/Ipamorelin 4Mg Vial 4Mg/4Mg Injectable
Compound - Estradiol Valerate 10Mg/Ml In Ethyl Oleate 10Mg/Ml Injectable
Compound - Estradiol Valerate 30Mg/Ml Inj #1 In Ethyl Oleate Oil Injectable
Compound - Estradiol Valerate 40Mg/Ml In Ethyl Oleate Inj Injectable
Compound - Estradiol Valerate 50Mg/Ml In Ethyl Oleate Inj Injectable
Compound - Estradiol Valerate 50Mg/Ml Inj #2 Injectable
Compound - Estradiol Valerate 5Mg/Ml In Ethyl Oleate 5Mg/Ml Injectable
Compound - Goal-Glutamine 75Mg/Ornithine 75Mg/Arginine 150Mg/Lysine 150Mg+Lidocaine 10Mg/Ml 75Mg/75Mg/150Mg/150Mg/10Mg/Ml Injectable
Compound - Hydroxocobalamin 1,000Mcg/Ml Inj Vial 1,000Mcg/Ml Injectable
Compound - Hydroxocobalamin 5,000Mcg/Ml Inj 5,000Mcg/Ml Injectable
Compound - Ic B Complex Inj Injectable
Compound - Ivme Hcg Vitamin B Inj (Contains No Hcg) Injectable
Compound - Ivme Super B Inj Injectable
Compound - L-Carnitine 250Mg/Ml Inj Injectable
Compound - Leucine 10Mg/ Isoleucine 15Mg/ Valine 40Mg/Ml (Bcaa) Inj 10Mg/15Mg/40Mg/Ml Injectable
Compound - Medroxyprogesterone Acet 150Mg/Ml Susp (Pf) 150Mg/Ml Suspension
Compound - Methylcobalamin 1Mg/Ml (1000Mcg/Ml) Inj 1Mg/Ml Injectable
Compound - Methylcobalamin 5Mg/Ml (5000Mcg/Ml) Inj 5Mg/Ml Injectable
Compound - Mic 20/40/50 /B Complex +Chrom/Carn 25/25Mg/Ml 20/40/50/25/25Mg/Ml Injectable
Compound - Mic 20/40/50 /B Complex +Chrom/Carn 25/25Mg/Ml+Lido 20/40/50/25/25Mg/Ml+Lido Injectable
Compound - Mic B Complex Inj-Miles Formulation Injectable
Compound - Mic B Complex W Chromium/ Methylcob (Boyden) Inj Injectable
Compound - Mic B Complex With Hydroxocobalamin 5Mg/Ml Inj Injectable
Compound - Mic B12 25/50/50/0.5Mg/Ml L-Carnitine 250Mg/Ml Injectable
Compound - Mic B12 25/50/50/1+B6 100 Mg/Ml Inj Injectable
Compound - Progesterone 100Mg/Ml Inj #1 In Ethyl Oleate Injectable
Compound - Quad-Mix Papav 20/Phentol 2/Pge-1 25/Atropine 0.2 Inj Injectable
Compound - Quad-Mix Papav 30/Phentol 1/Pge-1 10/Atropine 0.15 Inj Injectable
Compound - Quad-Mix Papav 30/Phentol 1/Pge-1 20/Atropine 0.1 Inj Injectable
Compound - Quad-Mix Papav 30/Phentol 2/Pge-1 20/Atropine 0.2 Inj *C5* Injectable
Compound - Quad-Mix Papav 30/Phentol 2/Pge-1 200/Atropine 0.02 Inj Injectable
Compound - Quad-Mix Papav 30/Phentol 2/Pge-1 30/Atropine 0.2 Inj Injectable
Compound - Quad-Mix Papav 30/Phentol 3/Pge-1 100/Atropine 0.2 Inj Injectable
Compound - Quad-Mix Papav 30/Phentol 4/Pge-1 40/Atropine 0.4 Inj *C6* Injectable
Compound - Sermorelin Acetate 15Mg/Ipamorelin 15Mg - Lyophilized 15Mg/15Mg Vial
Compound - Sermorelin Acetate 6Mg/Ipamorelin 6Mg - Lyophilized 6Mg/6Mg Vial
Compound - Sermorelin Acetate 9Mg/Ipamorelin 9Mg - Lyophilized 9Mg/9Mg Vial
Compound - Trimtropic - Mic B Complex/Chrom/Carn 20Mg/40Mg/50Mg/5Mg/33Mg/2Mg/1Mg/25Mcg/25Mg Injectable
Compound - Tri-Test 200 (Cy50%-En37.5%-Pr12.5%) Inj #1 200Mg/Ml Injectable
Compound - Ultra-Test (Cyp 80%/Prop 20%) 200Mg/Ml Inj #1 200Mg/Ml Injectable
Compound - Vitamin D3 100,000 Iu/Ml Injectable 100,000Iu/Ml
Compound - Test Cypionate 200Mg/Anastrozole 0.25Mg/Dutasteride 1Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 0.5Mg/Dutasteride 0.5Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 0.5Mg/Dutasteride 0.75Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 0.5Mg/Dutasteride 1.5Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 0.5Mg/Dutasteride 1Mg/Ml #2 Injectable
Compound - Test Cypionate 200Mg/Anastrozole 0.5Mg/Dutasteride 1Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 0.75Mg/Dutasteride 1Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 1.5Mg/Dutasteride 1.5Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 1.5Mg/Dutasteride 2Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 1Mg/Dutasteride 0.5Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 1Mg/Dutasteride 1.5Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 1Mg/Dutasteride 1Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 1Mg/Dutasteride 2Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 2Mg/Dutasteride 0.5Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Anastrozole 2Mg/Dutasteride 2Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Dutasteride 0.5Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Dutasteride 1Mg/Ml In Oil Injectable
Compound - Test Cypionate 200Mg/Dutasteride 2Mg/Ml In Oil Injectable
Compound - Testosterone Bi-Blend 100/100Mg/Ml Injectable
Compound - Testosterone Cypionate 100Mg/Ml Inj #1 In Ethyl Oleate Injectable
Compound - Testosterone Cypionate 200Mg/Anastrozole 0.25Mg/Ml In Oil Injectable
Compound - Testosterone Cypionate 200Mg/Anastrozole 0.5Mg/Ml Inj #1 In Ethyl Oleate Injectable
Compound - Testosterone Cypionate 200Mg/Anastrozole 0.5Mg/Ml Inj #2 In Sesame Oil Injectable
Compound - Testosterone Cypionate 200Mg/Anastrozole 0.75Mg/Ml In Oil Injectable
Compound - Testosterone Cypionate 200Mg/Anastrozole 0.7Mg/Ml In Oil Injectable
Compound - Testosterone Cypionate 200Mg/Anastrozole 1.5Mg/Ml In Oil Injectable
Compound - Testosterone Cypionate 200Mg/Anastrozole 1.75Mg/Ml In Oil Injectable
Compound - Testosterone Cypionate 200Mg/Anastrozole 1Mg/Ml #2 In Sesame Oil Injectable
Compound - Testosterone Cypionate 200Mg/Anastrozole 1Mg/Ml In Oil Injectable
Compound - Testosterone Cypionate 200Mg/Ml Inj #1 In Ethyl Oleate Injectable
Compound - Testosterone Cypionate 200Mg/Ml Inj #2 In Sesame Oil Injectable
Compound - Testosterone Cypionate 20Mg/Ml Inj #1 In Ethyl Oleate Injectable
Compound - Testosterone Cypionate 25Mg/Ml Inj #1 In Ethyl Oleate Injectable
Compound - Testosterone Cypionate 30Mg/Ml #1 In Ethyl Oleate Injectable
Compound - Testosterone Cypionate 50Mg/Ml Inj #1 In Ethyl Oleate Injectable
Compound - Tri-Mix Papav 23.3Mg/Phentol 1Mg/Pge-1 12Mcg/Ml Inj Injectable
Compound - Tri-Mix Papaverine 15/Phentolamine 0.25/Pge-1 6 Inj Injectable
Compound - Tri-Mix Papaverine 15/Phentolamine 0.5/Pge-1 5 Inj Injectable
Compound - Tri-Mix Papaverine 15/Phentolamine 1/Pge-1 10 Inj Injectable
Compound - Tri-Mix Papaverine 15/Phentolamine 2/Pge-1 20 Inj Injectable
Compound - Tri-Mix Papaverine 17.65/Phentolamine 0.59/Pge-1 5.9 Inj **T 101** Injectable
Compound - Tri-Mix Papaverine 18/Phentol 0.6/Pge-1 5.88/Ml Inj Injectable
Compound - Tri-Mix Papaverine 18/Phentol 0.6/Pge-1 6/Ml Inj Injectable
Compound - Tri-Mix Papaverine 20/Phentolamine 1/Pge-1 20 Inj Injectable
Compound - Tri-Mix Papaverine 23.3/Phentolamine 1/Pge-1 12 Inj Injectable
Compound - Tri-Mix Papaverine 25/Phentolamine 3/Pge-1 80 Inj Injectable
Compound - Tri-Mix Papaverine 25Mg/Phentolamine 1Mg/Pge1 25Mcg/Ml Inj Injectable
Compound - Tri-Mix Papaverine 26/Phentolamine 3/Pge-1 60/Ml Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 0.25/Pge-1 6 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 0.5/Pge-1 10 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 0.5/Pge-1 20 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 0.5/Pge-1 30 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 0.5/Pge-1 40 /Ml Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 1.5/Pge-1 50 Inj **St 1** Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 1/Pge-1 12 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 1/Pge-1 2.5 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 1/Pge-1 20 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 1/Pge-1 25 Inj**T 106** Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 1/Pge-1 30 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 1/Pge-1 40 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 1/Pge-1 5 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 2/Pge-1 20 Inj **T 104** Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 2/Pge-1 30 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 2/Pge-1 40 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 2/Pge-1 50 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 2/Pge-1 60 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 3/Pge-1 100 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 3/Pge-1 30 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 3/Pge-1 40 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 3/Pge-1 40 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 20 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 5 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 60 Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 7.5/Ml Inj Injectable
Compound - Tri-Mix Papaverine 30/Phentolamine 6/Pge-1 60 Inj Injectable
Compound - Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 10 Inj Injectable
Compound - Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 40 Inj Injectable
Ezetimibe and Simvastatin 10 mg/40mg Tablets
Ezetimibe and Simvastatin 10 mg/80mg Tablets
Tadalafil 5 mg Tablets
Tadalafil 20 mg Tablets
Acetaminophen 160 mg/5 mL Oral Suspension, Hospital Use Only
Acetaminophen 325 mg/10.15 mL Oral Suspension, Hospital Use Only
Cefixime 400 mg Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/10/2021
Methocarbamol 500 mg Tablet
Cubicin (daptomycin) 500 mg Injection, Single-dose vial
Ezetimibe and Simvastatin 10 mg/10 mg Tablets
Ezetimibe and Simvastatin10 mg/20 mg Tablets
Ezetimibe and Simvastatin 10 mg/80 mg Tablets
Ezetimibe and Simvastatin 10 mg/40 mg Tablets
Ezetimibe and Simvastatin 10 mg/40 mg Tablets
Irbesartan 75 mg Tablets
Irbesartan 150 mg Tablets
Irbesartan 300 mg Tablets
Irbesartan and Hydrochlorothiazide 150/12.5 mg Tablets
Irbesartan and Hydrochlorothiazide 300/12.5 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/03/2021
Calcium Chloride, 100 Mg/Ml Mdv Inj, Rx Only, Red Mountain Compounding Rx
Magnesium Chloride, 200 Mg/Ml Mdv Inj, Rx Only, Red Mountain Compounding Rx
Levocarnitine 100Mg/Ml Mdv Soln, Rx Only, Red Mountain Compounding Rx
Ascorbic Acid (Non-Corn) 500Mg/Ml Mdv Soln, Rx Only, Red Mountain Compounding Rx
Ascorbic Acid (Non-Corn) 500Mg/Ml Soln (Pf), Rx Only, Red Mountain Compounding Rx
Ascorbic/Glutathione 1.25/1.25% Opth Soln, Rx Only, Red Mountain Compounding Rx
Cyclosporine 0.2% Oil Opth Susp, Rx Only, Red Mountain Compounding Rx
Cyclosporine 2% Mct Oil Susp, Rx Only, Red Mountain Compounding Rx
Dexpanthenol 250Mg/Ml Inj Soln, Rx Only, Red Mountain Compounding Rx
Estradiol Valerate 5Mg/Ml Mdv Inj, Rx Only, Red Mountain Compounding Rx
Glutathione 200Mg/Ml Mdv, Rx Only, Red Mountain Compounding Rx
Hydroxyprog Caproate 250Mg/Ml Oil Inj, Rx Only, Red Mountain Compounding Rx
Levocarnitine 100Mg/Ml Mdv Soln, Rx Only, Red Mountain Compounding Rx
Pyridoxine Hcl (B6) 100Mg/Ml Mdv, Red Mountain Compounding Rx
Testosterone Cypionate 100Mg/Ml In Ethyl Oleate Oil, Rx Only, Red Mountain Compounding Rx
Testosterone Cypionate 200Mg/Ml In Sesame Oil Mdv, Rx Only, Red Mountain Compounding Rx
Testosterone Cypionate 200Mg/Ml Mdv Ethyl Oleate, Rx Only, Red Mountain Compounding Rx
Testosterone Cypionate 25Mg/Ml In Ethyl Oleate Mdv, Rx Only, Red Mountain Compounding Rx
Testosterone Cypionate 50Mg/Ml In Ethyl Oleate Oil, Rx Only, Red Mountain Compounding Rx
Testosterone Cypionate/Prop 160/40Mg/Ml Mdv In Ethyl Oleate, Rx Only, Red Mountain Compounding Rx
Testosterone Cypionate/Prop/Deca-Nan 125Mg/Ml (80/10/10) In Sesame Oil, Rx Only, Red Mountain Compounding Rx
Testosterone Cypionate/Prop/Deca-Nan 125Mg/Ml (80/10/10) In Sesame Oil, Rx Only, Red Mountain Compounding Rx
Testosterone Ultra 250Mg/Ml Mdv In Sesame Oil, Rx Only, Red Mountain Compounding Rx
Vitamin B Complex Inj Soln (Hp), Rx Only, Red Mountain Compounding Rx
Vitamin B Complex Inj Soln (Hp), Rx Only, Red Mountain Compounding Rx
Acetylcysteine 10% Opth Soln, Red Mountain Compounding Rx
Acetylcysteine 2% Opth Soln, Rx Only, Red Mountain Compounding Rx
Benzalkonium Chloride 0.013% Solution, Rx Only, Red Mountain Compounding Rx
Calcium Gluconate 10% Inj (Pf), Rx Only, Red Mountain Compounding Rx
Folic Acid 10Mg/Ml Mdv Inj, Rx Only, Red Mountain Compounding Rx
Methylcobalamin 10,000Mcg/Ml Mdv Inj, Rx Only, Red Mountain Compounding Rx
Methylcobalamin 1000Mcg/Ml Mdv Inj, Rx Only, Red Mountain Compounding Rx
Methylcobalamin 12.5Mg/Ml Mdv Inj Soln, Rx Only, Red Mountain Compounding Rx
Methylcobalamin 5000Mcg/Ml Mdv Inj, Rx Only, Red Mountain Compounding Rx
Mic 25/50/50Mg/Ml Mdv, Rx Only,Red Mountain Compounding Rx
Mic/B12A 25/50/50Mg/Ml 1Mg/Ml Mdv, Red Mountain Compounding Rx
Mic/B12A/B6 15/50/100 5Mg/50Mg/Ml Mdv, Rx Only, Red Mountain Compounding Rx
Mit/B12 25/50/50Mg/Ml 1Mg/Ml Mdv, Rx Only, Red Mountain Compounding Rx
Progesterone 100Mg/Ml Mdv Oil Injection, Rx Only, Red Mountain Compounding Rx
Sodium Selinite 200Mcg/Ml For Inj, Rx Only, Red Mountain Compounding Rx
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/27/2021
Glipizide 2.5 mg Extended-Release Tablets, (3 blister cards each with 10 individually blistered doses)
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder
AirDuo Digihaler 232/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour
Imipramine Pamoate 125 mg Capsules
Rocuronium Bromide 50mg/5 mL Injection, 5mL Multi-Dose Vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/20/2021
Daptomycin 500mg Injection
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag
Potassium Chloride Extended-Release 10 mEq (750 mg) Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/19/2021
Methocarbamol 500mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/14/2021
Irbesartan 75 mg Tablets
Irbesartan 150 mg Tablets
Irbesartan 300 mg Tablets
Irbesartan and Hydrochlorothiazide 150mg/12.5mg Tablets
Irbesartan and Hydrochlorothiazide 300mg/12.5mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/13/2021
Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin
Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle
Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/12/2021
Lidocaine Hydrochloride 4% (40 mg/mL) Topical Solution
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/06/2021
Lyrica CR (pregabalin) 330 mg extended release Tablets
Valproic Acid 500 mg/10 mL Oral Solution
Morphine Sulfate 2 mg per mL Injection, 1 mL single dose vial
Cefazolin, 2 Grams/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection
Cefazolin 3 Grams in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services
Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial
Sodium Phenylbutyrate 250 Grams Powder
Hydroquinone 4% Skin Bleaching Cream, Net Wt 1 oz (28.35g)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/01/2021
Lotrimin® Anti-Fungal (AF) Athlete's Foot Powder Spray 133 Grams
Lotrimin® Anti-Fungal (AF) Athlete's Foot Powder Spray 133 Grams - 3 pack
Lotrimin® Anti-Fungal Jock Itch (AFJI) Athlete's Foot Powder Spray 133 Grams
Lotrimin® Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray
Lotrimin® AF Athlete's Foot Liquid Spray 133 Grams (4.6 oz)
Lotrimin® AF Athlete's Foot Liquid Spray 133 Grams - 3 pack
Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray 133 Grams
Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray - 3 Pack
Lotrimin® Prevention Spray + Ultra AF Cream Economy Pack
Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray 160 Grams
Tinactin® Jock Itch (JI) Powder Spray 133 Grams
Tinactin® Athlete’s Foot Powder Spray 133 Grams
Tinactin® Athlete’s Foot Deodorant Powder Spray 133 Grams
Tinactin® Athlete’s Foot Liquid Spray 133 Grams
Tinactin® Athlete’s Foot Liquid Spray 150 Grams
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/29/2021
Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum
Chantix (varenicline) 0.5mg/1mg Tablets, 56 Tablets
Chantix (varenicline) 0.5mg Tablets, 56 Tablets
Chantix (varenicline) 1 mg Tablets, 56 Tablets
Chantix (varenicline) 1 mg Tablets
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single
Carbamazepine 200 mg Tablets
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only
Naproxen Sodium 275 mg Tablets
Naproxen Sodium 550 mg Tablets
Chlorzoxazone 375 mg Tablets
Chlorzoxazone 750 mg Tablets
Zonisamide 50 mg Capsules
Zonisamide 100 mg Capsules
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL)
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL)
Valproic Acid (250 mg/5 mL) Oral Solution USP, 1 Pint (473 mL)
Entacapone 200 mg Tablets
Metoprolol Tartrate 100 mg Tablets
Zonisamide 100 mg Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/26/2021
Glucagon Emergency Kit
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/22/2021
Lidocaine Hydrochloride 4% Topical Solution, 50 mL glass bottles
Aminosyn II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers
Betamethasone Dipropionate 0.05% Lotion (Augmented)
Oxycodone Hydrochloride 10 mg Tablets
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Compound
MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/21/2021
Cefazolin 2 gram in 20 mL syringe for injection
Cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/16/2021
Chantix 0.5 mg Tablets
Chantix 1 mg Tablets
Chantix 0.5/1 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/13/2021
Ruzurgi® (amifampridine) 10 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/08/2021
Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit, Due to a Mix-Up of the Diluent Included in the Kit
China_Gel (Camphor 3.00%, Menthol 5.00%) a Topical Pain Reliever
China_Gel White (Camphor 3.00%, Menthol 5.00%) a Topical Pain Reliever
Aulief (Organic Camphor 3.00% Organic Menthol 5.00%), Topical Pain Relief
Cyclobenzaprine Hydrochloride 7.5mg Tablets
Clopidogrel 75 mg Tablets
Naproxen Sodum 220 mg Tablets (Caplet)
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube
Ruzurgi® (amifampridine) 10 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/07/2021
Aminosyn II, 15%, An Amino Acid Injection, Sulfite
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/01/2021
Atovaquone 750 mg/5 mL Oral Suspension, 210 mL bottle
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags
Erythromycin 2% Topical Solution, 60mL bottle
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags
Micafungin 50 mg/vial for Injection, Single-Dose Vial
Micafungin 100 mg/vial for Injection, Single-Dose Vial
Sodium Phenylbutyrate Powder, 250 grams bottle
Fludarabine Phosphate 50 mg per vial for Injection, Single dose vial
Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box
Carvedilol 25 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/30/2021
Lidocaine HCl Topical Solution 4%
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/25/2021
Econazole Nitrate 1% Cream, 85 grams bulk shippers, packaged in tube
Triamcinolone Acetonide 0.1% Ointment, 80 g cartons, packaged in tubes
Tizanidine HCl 4 mg Tablets
Acetaminophen 325 mg Tablets, Regular Strength Pain Reliever
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution
Daunorubicin Hydrochloride 20 mg/4mL Injection
Methylprednisolone Acetate 40 mg/mL Injectable Suspension
Haloperidol Decanoate 100 mg/mL Injection
Amikacin Sulfate 1 gram/4mL (250mg/ML) Injection
Idarubicin Hydrochloride 20 mg/20 mL Injection
Vecuronium Bromide 10 mg for Injection
Octreotide Acetate 1000 mcg/5mL Injection
Leucovorin Calcium 350 mg/vial for Injection
Epoprostenol Sodium 1.5 mg/vial for Injection
Norepinephrine Bitartrate 4 mg/4 mL Injection
Adenosine 60mg/20mL (3 mg/mL) Injection
Metoclopramide 10 mg/2mL (5 mg/mL) Injection
Alprostadil 500 mg/mL Injection
Methylprednisolone Acetate 80 mg/mL Injectable Suspension
Octreotide Acetate 100 mcg/mL Injection
Octreotide Acetate 50 mcg/mL Injection
Leucovorin Calcium 100 mg/vial for Injection
Leucovorin Calcium 350 mg/vial for Injection
Adenosine 60mg/20 mL (3 mg/mL) Injection
Carvedilol 25 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/18/2021
Bupivacaine HCl-Baclofen PF Injectable 40mg-4000 mcg/ml, 21 ml Syringe
Bupivacaine HCl-Lioresal PF Injectable 7.5mg-1625mcg/ml, 41 ml Syringe
Fentanyl-Bupivacaine HCl Pf Injectable 3000 mcg-12mg/ml, 21 ml Syringe
Fentanyl-Bupivacaine HCl-Baclofen PF Injectable 575mcg-18mg-6000mcg/ml, 21 ml Syringe
Hydromorphone HCl-Bupivacaine Hcl-Baclofen PF Injectable 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML
Hydromorphone HCl-Bupivacaine HCl-Clonidine HCl Pf Injectable 21 ml Syringes In Two Strengths: A) 20mg-20mg-60mcg/ml Injectable, B) 5mg-5mg-100mcg/ml
Morphine-Bupivacaine Pf Injectable 21 ML, 22 ML, 23 ML, 41 ML And 43 ML Syringes In Various Strengths: A) 20mg/ML-40mg/ML, B) 15mg-30mg/ML, C) 5mg/ML-20mg/ML, D) 2mg-30mg/ML, E) 20mg-5mg/ML, F) 15mg-5mg/ML, G) 5mg-2mg/ML, H) 5mg-11mg/ML, I) 20mg-6mg/ML, J) 10mg-10mg/ML, K) 6mg-4.8mg/ML, L) 30mg-10mg/ML, M) 5mg-4mg/ML, N) 10mg/ML-20mg/ML, O) 40mg-5mg/ML, P) 20mg-20mg/ML, Q) 30mg-20mg/ML
Hydromorphone HCl-Bupivacaine Hcl-Fentanyl Pf Injectable 21 Ml Syringe In Various Strengths, A)10mg-20mg-100mcg/Ml, B) 20mg-10mg-450mcg/Ml, C) 13.3mg-3mg-3000mcg/Ml
Morphine-Hydromorphone-Bupivacaine Pf 13mg-19mg-2mg/Ml Injectable 21 Ml Syringe
Morphine-Bupivacaine-Ketamine Pf Injectable 21 Ml Syringe In Two Strengths: A) 5mg-25mg-5mg/Ml, B) 1mg-2mg-100mcg/Ml
Sufentanil-Bupivacaine-Baclofen Pf 25mcg-12.5mg-750mcg/Ml Injectable 41 Ml Syringe
Morphine-Bupivacaine-Fentanyl Pf 30mg-15mg-2000mcg/Ml Injectable 21 Ml Syringe
Hydromorphone HCl-Bupivacaine Hcl-Sufentanil Pf 25mg-9mg-110mcg/Ml Injectable 21 Ml Syringe
Hydromorphone HCl-Bupivacaine HCl Pf Injectable 21 And 22 Ml Syringes In Various Strengths: A) 0.5mg-5mg/Ml, B) 2mg-35mg/Ml, C) 25mg-15mg/Ml, D) 6mg-1.5mg/Ml, E) 3mg-3mg/Ml, F) 5mg-15mg/Ml, G)12mg-8mg/Ml, H)2mg-2mg/Ml, I) 30mg-30mg/Ml, J) 8mg-20mg/Ml, K) 20mg-10mg/Ml, L)50mg-3.5mg/Ml, M) 10mg-30mg/Ml, N)15mg-1.6mg/Ml, O) 20mg-30mg/Ml, P)15mg-6mg/Ml, Q)15mg-27mg/Ml
C-Progesterone oil 100 mg/ml, 10 ml vials, compound
Zyprexa (Olanzapine) Intramuscular for Injection, 10 mg per Single Use Vial
Sulfamethoxazole and Trimethoprim 800mg/160mg Double Strength Tablets
Venlafaxine 50 mg Tablets
Nystatin Oral Suspension, 100,000 units per mL, Cherry/Peppermint Flavor
Cimetidine Hydrochloride 300 mg/5 mL Oral Solution, 8 fl oz (237 mL)
Ethosuximide250 mg/5 mL Oral Solution, 16 fl oz (473 mL)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/16/2021
Chantix (varenicline) 0.5 mg Tablets
Chantix (varenicline) 1 mg Tablets
Chantix (varenicline) 0.5/1 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/11/2021
Chantix (varenicline) 0.5mg tablets, 56 Tablets
Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets)
Chantix (varenicline) 1 mg tablets, 56 Tablets
Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/10/2021
Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/04/2021
Estriol USP41 Micro 25 Grams
Azelaic Acid 99.0+% Micro 500 Grams
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/28/2021
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Compounded by: Innoveix Addison
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Compounded by: Innoveix Addison
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/21/2021
Solifenacin Succinate 10 mg Tablets
Nifedipine 30 mg Extended-Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/19/2021
Chantix (varenicline) 0.5 mg Tablets
Chantix (varenicline) 1 mg Tablets
Chantix (varenicline) 0.5/1 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/14/2021
Topotecan 4 mg/4mL (1 mg/mL) Injection, Single-Dose vial
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe.
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/13/2021
Compounded Lypohilized Injectable Semorelin / Ipamorelin 3mg
Compounded Lypohilized Injectable AOD-9604 3mg
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/01/2021
Topotecan 4 mg/4 mL (1 mg/mL) Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/30/2021
Diflorasone Diacetate 0.05% Ointment (15 grams or 30 grams)
DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles
Metformin Hydrochloride 750 mg Extended-Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/16/2021
Sodium Chloride 0.9%, 1000 mL
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/11/2021
Metformin Hydrochloride 750 mg Extended-Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/09/2021
0.5% Bupivacaine Hydrochloride 150 mg/30 mL (5 mg/mL) Injection, 30 mL Single-dose Teartop Vials
1% Lidocaine HCl 300 mg/30 mL (10 mg/mL) Injection, 30 mL Single-dose vial
Micardis (telmisartan Tablets) 80 mg Tablets
BusPIRone Hydrochloride 15 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/02/2021
NP Thyroid 15 Thyroid 15 mg (1/4 grain) Tablets
NP Thyroid 30 Thyroid 30 mg (1/2 grain) Tablets
NP Thyroid 60 Thyroid 60 mg (1 grain) Tablets
NP Thyroid 90 Thyroid 90 mg (1&1/2 grain) Tablets
NP Thyroid 120 Thyroid 120 mg (2 grain) Tablets
Niacin 250 mg Tablets (OTC)
Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units
Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days
Norvir Ritonavir 100 mg Tablets
Synthroid (levothyroxine sodium) Tablets in all pack sizes, styles and concentrations
Methocarbamol 500 mg Tablets
Fenofibrate 67 mg Capsules
Ofloxacin 0.3% 5 ml Ophthalmic
Lidocaine HCl Viscous 2% 100ml
Atropine Sulfate 1% Ophthalmic Solution For Topical Application To The Eye Sterile 5 mL
Cosopt (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10 mL Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution
Metoprolol Tartrate and Hydrochlorothiazide 50 mg/25 mg Tablets
Bromfenac Ophthalmic Solution 0.09% 1.7 ml
Vaniqa (eflornithine hydrochloride) 13.9% Cream, For Topical Use Only Net wt. 1.59 oz (45 g)
Ubrelvy 100 mg 10ud Cplt
Restasis 0.05%30x 0.4 ml Ophthalmic Preserved-free
Linzess (linaclotide) 72 mcg Capsules
Namzaric (memantine HCl extended release and donepezil HCl) 14 mg/10 mg Capsules
Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 grams
Vraylar (cariprazine) capsules in all pack sizes, styles and strengths
Nitrofurantoin Macrocrystals 25 mg Capsules
Buprenorphine and Naloxone Sublingual Film 4mg/1mg 30 Pouches Each Containing 1 Sublingual Film
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution)
Erythromycin 250 mg Tablets
Travoprost Ophthalmic 0.004% 2.5 mL Solution Drops
Enoxaparin Dofium Injrvyion, Upd 150mg/1ml 10x1ml Single Dose Syringes
Butorphanol Tartrate 10 mg/mL Nasal Solution 2. 5 mL bottle
Timolol Maleate 0.5% Ophthalmic Solution 2.5 mL Sterile For Topical Application In The Eye
Edarbi (azilsartan medoxomil) 80 mg Tablets
Edarbyclor Azilsartan Medoxomil and Chlorthalidone 40 mg*/12.5 mg Tablets
Edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone Tablets
Gemcitabine 200 mg/5.26 mL Vial
Brilinta ticagrelar 60 mg Tablets
Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations
Xigduo XR (dapgliflozin/metformin HCl extended-release) 10 mg/1000 mg Tablets
Xigduo XR (dapagliflozin/metformin HCl extended-release) 5 mg/1000 mg Tablets
Ibuprofen Oral Suspension 100 mg/5 ml 120 ml
Eletriptan Hydrobromide Tablets 20 mg 6(1x6) Unit-dose Tablets
Amoxicillin 500 mg Tablets
Ondansetron HCl 4 mg Tablets
Eszopiclone 3 Mg Tablets
Nuedexta (dextromethorphan HBr and quinidine sulfate) 20 mg/10 mg Capsules
Lotemax SM (Loteprednol Etabonate Ophthalmic Gel) 0.38% 5 gm
Benzefoam Emollient Foam Benzoyl Peroxide 5.3% 100gm Topical Emollient OTC, Foams
Muro-128 2% 15ml Ophthalmic OTC, Drops
Tobramy/Dex 0.3-0.1% 10ml Ophthalmic Drops
Dexameth Sod Phos 0.1% 5ml, Drops
Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each
Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each
Symproic (Naidemedine) 0.2 mg Tablets
Nurtec ODT (Rimegepant) 75 mg 8 pk Tablets For Rapid Dissolution (Not Sublingual)
Catapres-TTS-2 1x4
Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule
Atrovent HFA 17 mcg 12.9 Gm; Inhaler Medical Internal - May Or May Not Be Aerosol
Glyxambi (empagliflozin and linagliptin) 25 mg/5 mg Tablets
Synjardy (empagliflozin and metformin hydrochloride) 12.5 mg/1000 mg Tablets
Jentadueto XR (linagliptin and metformin hydrochloride extended-release) 5 mg/1000 mg Tablets
Synjardy XR (empagliflozin and metformin hydrochloride extended-release) 25 mg/1000 mg Tablets
Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) 12.5 mg/1000 mg Tablets
Pravachol 40 mg Tablets
Valsartan 40 mg Scored Tablets
Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g)
Meloxicam 7.5 mg Tablets
Nadolol 40 mg Tablets
Ciproflox/D5w 400/200 24 X 200 Ml Iv Solution (Piggyback)
Prilosec (Omeprazole Magnesium) 10 mg For Delayed-Release Oral Suspension
Iron 100 with Vitamin C Tablets Dietary Supplement
Benicar 40 mg Tablets
Pregabalin 300 mg Capsules
Phenobarbital 32.4 mg Tablets
Ivermectin 3 mg Tablets (2 Foil Strips of 10 tablets each)
Banzel (rufinamide)200 mg Tablets
Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intranasal spray per unit For use in the nose
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide Syrup 10-30-2mg/5ml 473 mL Syrup
Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women Unit Dose Tablets
Cathflo Activase (Alteplase) 2 mg
Flovent Diskus 100 mcg Inhaler Medical Internal - May Or May Not Be Aerosol
Advair HFA 45-21 mcg 12 gm Inhaler Medical Internal - May Or May Not Be Aerosol
Arnuity Ellipta 100 mcg 30 Inhalations - May Or May Not Be Aerosol
Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only
Trelegy Ellipta (Fluticasone Furoate, Umedidinium and Vilanterol Inhalation Powder) 100-62.5-25 mcg 60 Inhaler Medical Internal - May Or May Not Be Aerosol
Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg
Verapamil Hydrochloride 120 mg Extended-Release Tablets
Ezetimibe and Simvastatin 10-10 Mg Tablets
Theophylline (Anhydrous) 400 mg Extended-Release Tablets
Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets
Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g)
FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement
Bupropion Hydrochloride 75 mg Tablets
Acetazolamide 125 mg Tablets
Calcium Acetate 667 mg Capsules
Lithium Carb 150 mg Capsules
Leucovorin 15 mg Tablets
Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers
Tirosint (levothyroxine sodium) 175 mcg Capsules
Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement
Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each
Invega Sustenna 156mg/1ml Syringes
Auryxia (ferric citrate) 210 mg Tablets
Livalo (pitavastatin) 2 mg Tablets
Phentermine HCl 30 mg Capsules
Phentermine HCl 37.5 mg Capsules
Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz)
Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz)
Siladryl 12.5/5 mL 118 mL SF AF OTC Liquid
Pantoprazole Sodium 20 mg Delayed-Release Tablets
Nohist-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL)
Tri-Lo-Marzia 0.180mg/0.025mg; 0.215 Mg/0.025mg and 0.250mg/0.025mg 3x28 Bpk Tablets
Amlodipine and Olmesartan Medoxomil 10 mg/20 mg Tablets
Trazodone Hydrochloride 50 mg Tablets
Miconazole 7 2% 45 gm Applicator Cream OTC
Banophen (Diphenhydramine HCl) 25 mg Antihistamine
Acne Medication Benzoyl Peroxide Gel, 5% Net Wt 1.5 oz (42.5 g)
Vitamin D3 50 mcg Softgels OTC
Vitamin D3 25 mcg OTC Tablets
Vitamin D3 25 mcg OTC Tablets
Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment 28 gm OTC Ointment
Benzoyl Peroxide Wash 5% 148 ml OTC Liquid
Vitamin D3 50 mcg OTC Tablets
Carbidopa And Levodopa 25mg/100mg Tablets
Pedia-Lax 66ml OTC Enema
Belsomra (suvorexant) 10 mg Tablets. Each tablet contains 10 mg suvorexant
Belsomra (suvorexant) 20 mg Tablets. Each tablet contains 20 mg suvorexant
Steglatro (ertugliflozin) 15 mg Tablets
Asmanex Twist 220mcg 60 Inhalation Powder; Inhaler Medical Internal - May Or May Not Be Aerosol
Levothyroxine Sodium 125 mcg (0.125 mg) Tablets
Estradiol Transdermal System, 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day
Epinephrine Injection Auto-Injectors in all strengths, packs and styles
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt
Nat B Vitamin D3 2000u Otc Tablets
Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules
Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules
Tobrex 0.3% 3.5 gm Ophthalmic Ointment
Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile
Ciprodex (Ciprofloxacin 0.3 And Dexamethasone 0.1%) 7.5 ml Drops
Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs
Benztropine Mesylate Tablets, in all pack sizes, styles and strengths
Lamotrigine Extended-Release 250 mg Tablets
Zolpidem Tartrate Sublingual Tablet 3.5 Mg 30 Unit Dose Pouches; Each Pouch Contains One Sublingual Tablet
HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.)
Risperidone 1 mg/mL 30 ml Solution (Usually Not Otic, Opth, Nasal Drops)
Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g)
Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g)
Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses
Polyethylene Glycol 3350 Powder for Solution Osmotic Laxative 14 Once-Daily Doses 14 Packet- Newt Wt. 0.5 Oz (17g) Each
Fexofenadine Hydrochloride 180 mg Tablets, Non-Drowsy Antihistamine
Loratadine 10mg 24-Hour Non-Drowsy Tablets OTC
Cetirizine Hydrochloride 10 mg Tablets, OTC
Podofilox Topical Solution 0.5% 3.5 mL For Topical Use Only
Hydrocortisone Acetate 30 mg Suppository
Triamcinolone Acetonide 0.025% Ointment, 80 grams
Lyrica (pregabalin) 200 mg Capsules
Methotrexate Injection, 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile
Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets)
Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets)
Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets)
Levoxyl 150 mcg Tablets
Promethazine Plain Oral Solution 6.25mg/5ml 473 ml; Solution (Usually Not Otic, Opth, Nasal Drops)
Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation
Aerosol 120 inhalations
Medroxyprogesterone acetate 150 mg per mL 1 mL injectable suspension, Prefilled Syringe
Medroxyprogesterone acetate 150 mg/mL 1 mL injectable suspension
Cefazolin for Injection 1 gram per vial Rx Only Single-use Vial Sterile
Hydrocortisone 1% 30gm cream
Tuberculin Purified Protein Derivative (Mantous) Tubersol, Stabilized Solution 5 US Units
Collagenase Santyl Ointment 250 units/g 30 grams
Clindamycin Hydrochloride 150 mg Capsules
COREG CR (carvedilol phosphate) 80 mg Extended Release Capsules
Trokendi XR (topiramate) 100 mg Extended-Release Capsules
Colcrys (colchicine) 0.6 mg Tablets
Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL)
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8.5 g Net Contents
Neomycin Sulfate 500 mg Tablets
Bisoprolol Fumarate and Hydrochlorothiazide 2.5 mg/6.25 mg Tablets
Penicillin V Potassium for oral solution 125mg/5ml 100ml (when mixed)
Epinephrine Injection, 0.3 mg (Auto-Injectors) For Allergic Emergencies (Anaphylaxis) 2 Auto-Injectors And 1 Trainer
Epinephrine Injection, 0.15 mg (Auto-Injectors) For Allergic Emergencies (Anaphylaxis) 2 Auto-Injectors And 1 Trainer
Balziva 28 Day (norethindrone and ethinyl estradiol) 6 Blister Card Dispensers, 28 tablets each
Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g
Desvenlafaxine 25 mg Extended-Release Tablets
Sulindac 200mg Tablets
Darifenacin 7.5 mg Extended-release Tablets
Darifenacin 15 mg Extended-release Tablets
Tramadol Hydrochloride 100 mg Tablets
Integra 325/40/3mg
Vimpat (lacosamide) 100 mg Tablets
Vimpat (lacosamide) 200 mg Tablets
Briviact (brivaracetam) 50 mg Tablets
Amantadine Hydrochloride 100 mg Tablets
Haloperidol 20 mg Tablets
Corgard (nadolol) 40 mg Tablets
Cyanocobal Injection 1000 mcg/ml 25x1ml;
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup
Enalapril Maleate 2.5 mg Tablets
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr)
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/26/2021
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags
Sterile Water for Injection, 25 x 100 mL Single Dose Vials per carton
Metformin HCl (Generic for Glucophage XR) 500 mg Extended Release Tablets
Cefixime for Oral Suspension 100 mg/5mL, 50mL HDPE bottles
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), For IM or IV Use
Haloperidol Decanoate 50 mg/mL Injection, 1 mL Single Dose Vials
Methylprednisolone Acetate 40 mg/mL Injectable Suspension, 10 mL Multiple Dose Vial
Metoclopramide 10 mg/2 mL (5 mg/mL) Injection, 2 mL Single-Use Vial
Haloperidol Decanoate 100 mg/mL Injection, 1 mL Single Dose Vials
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/19/2021
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution
Metformin HCl 500 mg Extended-Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/12/2021
Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/05/2021
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each
Cephalexin (Keflex) 250 mg/5mL for Oral Suspension, Pkg Size 100
Losartan Potassium 50 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/04/2021
0.5% Bupivacaine Hydrochloride 0.5%, 150 mg/30mL (5 mg/mL) Injection, 30 mL
1% Lidocaine HCl 1%, 300 mg/30 mL (10 mg/mL) Injection, 30 mL
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/30/2021
NP Thyroid 15 mg Tablets
NP Thyroid 30 mg Tablets
NP Thyroid 60 mg Tablets
NP Thyroid 90 mg Tablets
NP Thyroid 120 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/28/2021
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (Do Not Inject) Sterile Ophthalmic Solution, Preservative Free
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box
Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/21/2021
Cefprozil 250mg/5mL for Oral Suspension, 50 mL (when mixed) bottle
Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz.
Itraconazole 100 mg Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/14/2021
Telmisartan 20 mg Tablets
Neomycin Sulfate 500 mg Tablets
Ganirelix Acetate 250 mcg/0.5 mL Injection
Mometasone Furoate 0.1% Topical Solution (Lotion)
Guanfacine 2 mg Extended-Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/07/2021
Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) Vial
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) Vial
ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with Zomacton (somatropin) for injection 5mg vial
ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with Zomacton (somatropin) for injection 10 mg vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/02/2021
Acetaminophen Extra Strength 500 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/31/2021
Guanfacine 2 mg Extended-Release Tablets
0.9% Sodium Chloride Irrigation, 1000 mL Semi-Rigid Bottle
Omeprazole 20 mg Delayed Release Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/25/2021
Acyclovir Sodium 50 mg/mL Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/24/2021
Telmisartan 20 mg Tablets
Spironolactone 25 mg Tablets
Spironolactone 50 mg Tablets
Nortriptyline HCL 10 mg Capsules
Gabapentin 250 mg/5 mL Oral Solution, 5 mL per unit dose cup
Phenylephrine HCl 10 mg per mL Injection, 1 mL per Single-Dose Vial
Omeprazole Delayed-Release 20 mg Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/11/2021
Phenylephrine Hydrochloride 10 mg/mL Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/10/2021
Famotidine 40 mg Tablets
Metoclopramide 10 mg/2 mL (5 mg/mL) Injection, 25x2mL Single Dose Vials
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton
Progesterone 200 mg Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/09/2021
Spironolactone 25 mg Tablets
Spironolactone 50 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/03/2021
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each
ChlroraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each
Cisatracurium Besylate 10mg per 5mL (2 mg per mL) Injection
Dacarbazine 200 mg Injection
Desmopressin Acetate 4 mcg/mL Injection
Sterile Diluent for Epoprostenol Sodium for Injection
Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng)
Methylpredisolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial
Leucovorin Calcium 100 mg/vial Injection
Metoclopramide 10 mg/2 mL (5 mg/mL) Injection
Toposar (etoposide) 1 gram/50 mL (20 mg/mL) injection
Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL
Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng)
Methylpredisolone Acetate 80 mg/mL Injectable Suspension
Methylpredisolone Acetate 400 mg/10 mL (40 mg/mL) Injectable Suspension
Methylpredisolone Acetate 200 mg/5 mL (0 mg/mL) Injectable Suspension
Methylpredisolone Acetate 400 mg/5 mL (80 mg/mL) Injectable Suspension
Leucovorin Calcium 350 mg/vial Injection
Imatinib Mesylate 100 mg Tablets
Irinotecan Hydrochloride 40 mg/2 mL (20 mg/mL) Injection
Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/24/2021
Cephalexin 250 mg per 5 mL for Oral Suspension, 100 ml (when mixed)
Cephalexin 250 mg per 5 mL for Oral Suspension, 200 ml (when mixed)
Meclizine HCl 12.5 mg Tablets
Meclizine HCl 25 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/17/2021
Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes
Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes
Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/10/2021
Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial
Nortriptyline HCl Capsules, equivalent to 10mg base
Metformin Hydrochloride 750 mg Extended-Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/03/2021
Ketorolac Tromethamine 30 mg per mL Injection
Enoxaparin Sodium 100 mg/mL Injection
Enoxaparin Sodium 120 mg/mL Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/27/2021
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile
Human Chorionic Gonadotropin 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved
Human Chorionic Gonadotropin 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved
Human Chorionic Gonadotropin 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved
Human Chorionic Gonadotropin 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only.
Nitrofurantoin (Monohydrate/Macrocrystals) 100 mg Capsules
Cisatracurium Besylate 10mg per 5mL Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/25/2021
Metformin HCl 750 mg Extended Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/20/2021
Levetiracetam Oral Solution, 100 mg/mL
Paroex (Chlorhexidine Gluconate) 0.12% Oral Rinse, Alcohol Free
Metformin Hydrochloride 750 mg Extended-Release Tablets
Chlorhexidine Gluconate 0.12% Oral Rinse
Methotrexate, Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Syringe for IM Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/13/2021
Cephalexin for Oral Suspension 125 mg per 5 mL
Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe
Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe
Ephedrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe
Ephendrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe
Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe
Fentanyl 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe
Fentanyl 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe
Fentanyl 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe
Hydromorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL)
Hydromorphon HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL)
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII
Labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL)
Lidocaine HCl 1% 10 mL (10mg/ml)
Lidocaine HCl 2% 5 mL, 20 mg/mL
Morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL)
Neostigmine methylsulfate 5 mg/5 mL, (1mg/ml)
Phenylephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL)
Phenylephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL)
Rocuronium Br 100 mg/10mL (10 mg/mL)
Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL)
Succcinylcholine Chloride 200 mg/10 mL, (20 mg/mL)
Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII
Phenylephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL)
Rocuronium Br 50 mg/5mL (10 mg/mL)
Succinylcholine Chloride 100 mg/5mL
Ephedrine 25 mg/5 mL in 0.9% Sodium Chloride Injection
Fentanyl 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII
Hydromorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII
PhenylLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL)
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII
Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/08/2021
Ketorolac Tromethamine 30 mg/mL Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/06/2021
Ketorolac Tromethamine Injection, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial
Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial
Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial
Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed)
Cephalexin for Oral Suspension, 250 mg per 5 mL 200 ml (when mixed)
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/04/2021
Metformin HCl 750 mg Extended Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/31/2020
Paroex Chlorhexidine Gluconate 0.12% Oral Rinse, 15 mL unit dose cups
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/30/2020
Paroex Chlorhexidine Gluconate 0.12% Oral Rinse
Hydroxyzine Hydrochloride 10 mg/5 mL Oral Solution (Syrup)
Auryxia (ferric citrate) 210 mg Tablets
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial
Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/23/2020
Trazodone Hydrochloride 100 mg Tablets
CJC-1295, 2000 mcg/mL, 5 mL Vial
FGL, 10 MG/mL, 3 mL Vial
PT-141, 10 mg/mL, 2 mL Vial
AOD-9604, 1200 mcg/mL, 5 mL Vial
BPC-157, 2000 mcg/mL, 5 mL Vial
Thymosin Alpha, 2000 mcg/mL, 5 mL Vial
Ipamorelin, 2000 mcg/mL, 5 mL Vial
GHRP, 2000 mcg/mL, 5 mL Vial
Nandrolone, 200 mcg/mL, 2 mL
B12 for Injection, 2 mg/mL, 10 mL Vial
DSIP, 1000 mcg/mL, 5 mL Vial
Cerebrolysin, 107.5 MG/mL, 10 mL Vial
Thymosin Beta - 4, 2000 mcg/mL, 5 mL Vial
GHK-CU, 10 MG/mL, 5 mL Vial
High Dose E B12, 10 mg/mL, 10 mL Vial
LL-37, 2000 mcg/mL, 2 mL Vial
Pentosan Polysulfate, 300 mg/mL, 5 mL Vial
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums
CVS Health Athlete's Foot Cream, Clotrimazole 1% Cream , Antifungal, (28.4 g)
Equate Athlete's Foot, Clotrimazole 1%, Antifungal Cream, (14.2g), (60g)
H-E-B - Athlete's Foot Cream Clotrimazole 1% Cream, (14.2 g)
Kaiser Permanente Clotrimazole 1% Cream, Antifungal Cream, (28.4 g)
Kroger Athlete's Foot Cream, Clotrimazole 1% Cream, Antifungal, (15g)
Kroger Jock Itch Cream, Clotrimazole 1% Cream, Antifungal Cream, (15 g)
RiteAid Pharmacy RIngworm Cream, Clotrimazole 1% Cream, Antifungal (14.2g)
Best Choice, Clotrimazole 1% Cream, Antifungal, (14.2g)
TopCare Health, Athlete's Foot Cream, Clotrimazole 1% Cream, Antifungal, (14.2 g)
Athlete's Foot Cream, Clotrimazole 1% Cream, Antifungal Cream, (30 g)
Lansoprazole Delayed-Release 15 mg Orally Disintegrating Tablets
Lansoprazole Delayed-Release 30 mg Orally Disintegrating Tablets
Sildenafil 100 mg Tablets
Vumerity (diroximel fumarate) 231 mg Delayed-Release Capsule
Sodium Chloride 0.9% Injection, 0.308 mOsmol/mL, 2mL Single Dose Vial
Azacitidine for Injection 100 mg/Vial For Subcutaneous and Intravenous Use Only Single-Dose Vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/16/2020
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle
Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent
Imatinib Mesylate 100 mg Tablets
Imatinib Mesylate 400 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/09/2020
Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups
Regenecare HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g)
Aripiprazole 15 mg Tablets
Aripiprazole 15 mg Tablets per unit dose carton
Anagrelide 1 mg Capsule
Sildenafil 100 mg Tablets
Trazodone 100 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/02/2020
Paroex (chlorhexidine gluconate) 0.12% Oral Rinse, Alcohol Free
Clomipramine Hydrochloride 50 mg Capsules
/Levetiracetam 500 mg Tablets
Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/25/2020
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free
Metformin HCl 500 mg Extended Release Tablets
Aripiprazole 15 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/19/2020
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg /50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/18/2020
Bupivacaine Hydrochloride in 8.25% Dextrose Injection, Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules
Mesalamine 1.2 gram Delayed-Release Tablets
Mesalamine 1.2 gram Delayed-Release Tablets (Once-Daily)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/11/2020
Metformin Hydrochloride 500 mg Extended-Release Tablets
Metformin Hydrochloride 750 mg Extended-Release Tablets
Chlorhexidine Gluconate 20%
Lansoprazole 15 mg Delayed-Release Orally Disintegrating Tablets
Lansoprazole 30 mg Delayed-Release Orally Disintegrating Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/09/2020
Gluconate 0.12% Oral Rinse
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/04/2020
Catapres (clonidine hydrochloride, USP) 0.1 mg Tablets
Catapres (clonidine hydrochloride, USP) 0.2 mg Tablets
Catapres (clonidine hydrochloride, USP) 0.3 mg Tablets
Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes
Metformin Hydrochloride Extended Release 750 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/02/2020
Metformin HCl 750 mg Extended Release Tablets
Metformin HCl 500 mg Extended Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/28/2020
Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz
NP Thyroid 15, Thyroid 1/4 grain (15 mg) Tablets
NP Thyroid 120, Thyroid 2 grain (120 mg) Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/15/2020
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/14/2020
Diethylpropion 25 mg Tablets
Diethylpropion 75 mg Tablets
Phentermine 30 mg Capsules
Ranitidine 150 mg Tablets
Ranitidine 300 mg 30 Tablets
Losartan Potassium 100 mg 30 Tablets
Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/07/2020
Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg)
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton
pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box
Riomet ER (metformin hydrochloride for extended-release oral suspension) 500 mg per 5 mL 16 oz. For Oral Use
Losartan Pot/HCTZ 50/12.5 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/05/2020
Metformin HCL ER 500 mg Tablets
Metformin HCL ER 750 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/30/2020
Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch
Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg
Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg
Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/24/2020
Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy Medicine
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/23/2020
RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL
Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/21/2020
Albuterol Inhaler (At the Retail Level only)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/16/2020
Cephalexin 250 mg per 5 mL for Oral Suspension
Vancomycin HCL 1.5 mg
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/09/2020
Amiodarone Hydrochloride 450 mg/9 mL (50 mg/mL) Injection
Tranexamic Acid 1000 mg/10 mL (100 mg/mL) Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/03/2020
Nature-Throid 0.50 grain Tablets
Nature-Throid 0.75 grain Tablets
Nature-Throid 1.00 grain Tablets
Nature-Throid 1.25 grain Tablets
Nature-Throid 1.50 grain Tablets
Nature-Throid 1.75 grain Tablets
Nature-Throid 2.00 grain Tablets
Nature-Throid 2.50 grain Tablets
Nature-Throid 3.00 grain Tablets
WP Thyroid 0.50 grain Tablets
WP Thyroid 0.75 grain Tablets
WP Thyroid 1.00 grain Tablets
WP Thyroid 1.25 grain Tablets
WP Thyroid 1.50 grain Tablets
WP Thyroid 1.75 grain Tablets
WP Thyroid 2.00 grain Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/02/2020
Dexmedetomididne HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle
Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container for Intravenous Use (5 units/mL)
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container for Intravenous Use (10 units/mL)
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container for Intravenous Use (5 units/mL)
Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container for Intravenous Use (10 units/mL)
Sulfamethoxazole and Trimethoprim 800 mg/160 mg Double Strength Tablets
Losartan Potassium 50 mg Tablets
Buspirone Hydrochloride 7.5 mg Tablets
Buprenorphine HCl 0.3 mg/mL Injection, 1 mL vial
Metformin Hydrochloride Extended-Release 500 mg Tablets
Metformin Hydrochloride Extended-Release 750 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/31/2020
Amiodarone HCl 450 mg/9 mL10 Injection x 9 mL single-dose vials
Tranexamic Acid 1000 mg/10 mL Injection 10 x 10 mL single-dose vials
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/26/2020
Invokana, Invokamet, Invokamet XR (canagliflozin)
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator
DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap
STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap
Hydrochlorothiazide 25 mg Tablets
Hydrochlorothiazide (HCTZ) 25 mg Orange Tablets
Hydrochlorothiazide 50 mg Tablets
Thyroid 1 Grain Tablets
Thyroid Neutral 2 Grain Tablets
Topiramate 25 mg Tablets (White/round tablets)
Phendimetrazine 35 mg Yellow Tablets
Phendimetrazine 105 mg Brown/Clear Capsules
Phentermine HCL 15 mg Gray/Yellow Capsules
Phentermine 15 mg Grey/Yellow Capsules
Phentermine HCL 15 mg GrayYellow Capsules
Phentermine HCL 30 mg Yellow Capsules
Phentermine HCL 30 mg Blue/Clear Capsules
Phentermine HCL 37.5 mg Blue/White Capsules
Phentermine HCL 37.5 mg White/Blue Speckled Tablets
Phentermine HCL 37.5 mg Blue Speckled Tablets
Prednisone 2.5 mg Tablets
Elitek (rasburicase) for injection, 7.5 mg vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/20/2020
Metformin Hydrochloride 500 mg Extended-Release Tablets
Metformin Hydrochloride 750 mg Extended-Release Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/19/2020
Lidocaine Patch 5%, packaged in 30-count cartons
Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg
Nystatin 100,000 units per mL Oral Suspension, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL)
Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles
Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles
Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles
Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear
Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/18/2020
Compounded Product: Heparin Sodium 10 units/mL in 0.9% Sodium Chloride 500 mL Bag (5,000 units/500 mL)
Compounded Product: Heparin Sodium 5 units/mL in 0.9% Sodium Chloride 500 mL Bag (2,500 units/500 mL)
Compounded Product: Heparin Sodium 10 units/mL in 0.9% Sodium Chloride 1,000 mL Bag (10,000 units/1,000 mL)
Compounded Product: Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000mL Bag (5 units/mL)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/12/2020
Daptomycin 500 mg/vial for Injection, Single-Dose Vial
VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate)
VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate)
Fentanyl Citrate Injection, 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/05/2020
Calcium citrate tetrahydrate powder, 100 gm container
D-Biotin 300 mg Capsule, 90 capsules per bottle
Estriol 6 mg Capsule, 90 capsules per bottle
Estriol 8 mg Capsule, 90 capsules per bottle
Finasteride Plus 1.25mg Capsule, 90 capsules per bottle
Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15 mL) bottle
Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle
Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle
Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle
Progesterone 150 mg Troche, 30 troches
Progesterone 300 mg Troche, 30 troches per bottle
Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle
Progesterone 200 mg Troche, 30 troches per bottle
Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle
Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle
Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle
Sildenafil 50 mg Troche, 30 troches per bottle
Tadalafil 12 mg Capsule, 90 capsules per bottle
Tadalafil 18 mg Capsule, 90 capsules per bottle
Tadalafil 26 mg Capsule, 90 capsules per bottle
Tadalafil 3 mg Capsule, 90 capsules per bottle
Tadalafil 7 mg Capsule, 90 capsules per bottle
Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle
Vardenafil 20 mg Troche, 30 troches per bottle
Yohimbine HCL 5.4mg Capsule, 90 capsules per bottle
Lisinopril 10 mg Tablets
DDAVP® Nasal Spray 10 mcg/0.1mL
Desmopressin Acetate Nasal Spray 10 mcg/0.1mL
STIMATE® Nasal Spray 1.5 mg/mL
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/29/2020
Cefdinir 250 mg/5mL for Oral Suspension
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/22/2020
Metformin Hydrochloride Extended-Release 750 mg Tablets
Metformin Hydrochloride Extended-Release 500 mg Tablets
Metformin Hydrochloride Extended-Release 1000 mg Tablets
Lidothol Patch, Lidocaine 4.5% & Menthol 5%
Carbamazepine 200 mg Tablets, 100-unit dose tablets per box
Auryxia (ferric citrate) 210 mg Tablets
Dexmedetomidine Hydrochloride 200 mcg/50 mL Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/15/2020
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/08/2020
Metformin Hydrochloride Extended-Release 500 mg Tablets
Metformin Hydrochloride Extended-Release 1000 mg Tablets
Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, compounded drug not for resale
Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin
(expectorant), 4 FL OZ. bottle (118 mL)
Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/07/2020
Daptomycin 500 mg/vial for Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/03/2020
Metformin Hydrochloride Extended-Release 750 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/01/2020
Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
Sterile Curcumin, 4mg/mL, 10mL vial
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
Sterile Curcumin 50mg/mL, 10 mL vial
Metformin Hydrochloride Extended-Release 500 mg Tablets
Metformin Hydrochloride Extended-Release 750 mg Tablets
Metformin Hydrochloride Extended-Release Tablets, Bulk,
Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL)
Nystatin 100,000 units per gram Cream, 30 grams
Nystatin 100,000 units per gram Cream, 15 grams
Aripiprazole 2 mg Tablets
Clozapine 100mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/24/2020
Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL)
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL)
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL)
Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL)
Metformin Hydrochloride Extended-Release 500 mg Tablets
Metformin Hydrochloride Extended-Release 750 mg Tablets
Metformin HCl ER 500 mg
Irinotecan HCl 100mg/5mL Injection
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/18/2020
Children's Robitussin Honey Cough and Chest Congestion DM
Children's Dimetapp Cold and Cough
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/17/2020
Ketorolac Tromethamine 30 mg per mL Injection
Ketorolac Tromethamine 60 mg per 2 mL (30 mg per mL) Injection
Doxycycline Hyclate 100 mg Tablets
Unasyn (ampicillin sodium/sulbacatam) 1.5 g* per vial for injection
Lisinopril 5 mg Tablets
Oxytocin 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/11/2020
Metformin Hydrochloride Extended-Release 500 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/10/2020
NP Thyroid 30, Thyroid 1/2 grain (30 mg) Tablets
NP Thyroid 60, Thyroid 1 grain (60 mg) Tablets
NP Thyroid 90, Thyroid 1 & 1/2 grain (90 mg) Tablets
Doxycycline Hyclate 100 mg Tablets
Estriol Micronized 5 G
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/05/2020
Metformin Hydrochloride Extended-Release 500 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/03/2020
Doxycycline Hyclate 100 mg Tablets
Doxycycline Hyclate 100 mg Tablets
LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch
LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch
Mencaine (lidocaine 4.5%, menthol 5%) Patch
Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/01/2020
Metformin Hydrochloride Extended-Release 500 mg Tablets
Metformin Hydrochloride Extended-Release 750 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/28/2020
Metformin Hydrochloride Extended-Release 500 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and
05/27/2020
Lactated Ringer's Injection 1000 mL flexible container
Aloprim (allopurinol sodium) 500 mg for Injection Single-Dose Vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/22/2020
NP Thyroid 30 mg Tablets
NP Thyroid 60 mg Tablets
NP Thyroid 90 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/20/2020
Finasteride Plus 1.25 mg Capsule, 30, 90-count Bottle, Compounded Product Not for Resale
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/13/2020
Epinephrine Injection 0.3 mg (Auto-Injector) 0.3 mg/ 0.3 mL pre-filled syringe
Infuvite Pediatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/11/2020
Finasteride Plus 1.25mg Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/08/2020
Lactated Ringer’s Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/06/2020
Ceftazidime 2 g for Injection and Dextrose for Injection 50 mL Duplex Container
Nizatidine 15 mg/mL (75 mg/5mL) Oral Solution
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/29/2020
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box
Cefixime 100mg/5mL for Oral Suspension
Lisinopril 20 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/27/2020
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/22/2020
Acetaminophen and Codeine Phosphate 300 mg/15 mg Tablets
Acetaminophen and Codeine Phosphate 300 mg/30 mg Tablets
Acetaminophen and Codeine Phosphate 300 mg/60 mg Tablets
Gabapentin 100 mg Capsules
Levetiracetam 750 mg Tablets
Simvastatin 40 mg Tablets
Mirtazapine 15 mg Tablets
Phentermine Hydrochloride 15 mg Capsules
Oxycodone and Acetaminophen 10 mg*/325 mg Tablets
Losartan Potassium 25 mg Tablets
Estriol Vaginal Cream (0.1%) 1 mg Cream 30 gm tubes
Testosterone W/Cosmetic HRT Base 100 mg (10%) Cream 30 gm
Fluorouracil (5-FU) 4.5% Cream 100 gm
Bi-Est8:2/Progesterone/Testosterone 1.0/50 mg/0.5 mg/mL Cream 30 gm tube
Bi-Est8:2/Progesterone/Testosterone 1.0/50 mg/0.5mg/mL Cream 30 gm
Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle
Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream 30 gm tube
Estradiol Vaginal Cream 0.01% Cream 30 gm tube
Testosterone w/ Atrevis 20 mg (2%) Cream 30 gm tube
Testosterone w/ Atrevis 100 mg/mL Gel, 90 gm pump
Estradiol 1.8 mg capsule, 30 capsule bottle
Bi-Est (1:1) Progesterone/Testosterone 0.5 mg/40 mg/10.5 mg/mL Cream 30 gm tube
Bi-Est (8:2) Progesterone/Testosterone 2/80/3 mg/mL cream 30 gm tube
Bi-Est (1:1) Progesterone/Testosterone0.5 mg/1.5 mg/mL cream 60 gm tube
Bi-Est (1:1) Progesterone/Testosterone 1.0 mg/60 mg/0.5 mg/mL Cream 60 gm tube
Progesterone/Versa Base 20 mg (2%) Cream 30 gm tube
Progesterone 200 mg Capsules, 90 capsules
Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tube
Bi-Est (8:2)/DHEA/Testosterone 0.8 mg/ 9/0.4 mg/0.2 mg/mL Cream 6 gm tube
Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube
Ergotamine Tartrate 1 mg/Caffeine 100 mg Base Suppository (Pink) 48 count box
Diethylstilbestrol 1 mg capsule 300 capsules bottle
Bi-Est 8:2/Progesterone 2.5 mg/150/mL Cream 30 gm tube
Bi-Est 8:2/Progesterone/Testosterone DHEA 4.0/100/1/25.0 mg capsules, 90 capsules bottle
Bi-Est 1:1/Progesterone/Testosterone 2.0/100/0.25 mg/mL Cream 30 gm tube
Bi-Est 1:1/Progesterone/DHEA 1/40/5 mg/mL Cream 30 mL jar
Bi-Est 1:1/Progesterone/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar
Bi-Est (8:2)/Progesterone/Test/DHEA 6/50/0.5/10 mg/mL Cream 30 mL
Bi-Est (50/50)/Progesterone 1.25 mg/80 mL Cream 30 gm tube
Testosterone in Atrevis 50 mg/mL Gel 30 gm tube
Paregoric Compound (contains Morphine) Solution 480 mL bottle
Hydromorphone Oral 1 mg/mL Solution 240 mL, bottle
Clobetasol Mouth Rinse 0.05% Solution 450 mL bottle
Naltrexone 4.5 mg/mL Suspension 30 mL bottle
Estriol 5 mg Suppository, 36 each box
Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream 100 gm tube
Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube
Bi-Est (1:1)/Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL Cream 30 gm tube
Bi-Est (50/50)/Progesterone/Testosterone 1.5 mg/40 mg/0.5 mg/mL Cream 30 gm tube
Bi-Est (50/50)/Progesterone/Testosterone 1.5/100/0.5 mg Cream 30 gm tube
Bi-Est (8:2)/Progesterone 2/100 mg/mL capsule 90 caps bottle
Bi-Est (50/50/Progesterone 0.2 mg/70 mg Cream 30 gm jar
Bi-Est (1:1)/PProgesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL bottle
Bi-Est (8:2)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar
Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar
Paregoric Alternate Elixir 300 mL bottle
Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar
Testosterone in Atrevis 75 mg/mL Gel 90 gmS tube
Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar
Testosterone w/Cosmetic HRT Base 20 mg (2%) Cream 30 gm jar
Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar
Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 suppositories
Betahistine 16 mg Capsule, 180 capsules bottle
Levothyroxin (T4)/Liothyronine (T3) SR 130 mg/175 mg capsule, 21 capsules bottle
Estradiol (Non-Micronized) (Hemihydrate)
Acetaminophen and Codeine Phosphate 300/30 mg tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/21/2020
TRUE METRIX AIR Blood Glucose Meter
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/20/2020
Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 mL) in Duplex® Container
Ketorolac Tromethamine 30 mg/mL Injection
Ketorolac Tromethamine 60 mg/2mL Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/16/2020
Tetracycline HCl 250 mg Capsules
Tetracycline HCl 500 mg Capsules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/15/2020
Ephedrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free
Nicardipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection, 10 ml in a 20mL syringe
Rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use
Hydromorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe
Fentanyl Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%
Succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use
Rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use
Ephedrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free
Fentanyl Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe
Ephedrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use
Ephedrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use
Fentanyl Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use
Fentanyl Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use
Losartan Potassium 50 mg Tablets
Losartan Potassium 100 mg Tablets
Losartan Potassium 25 mg Tablets, Bulk
Losartan Potassium 50 mg Tablets, Bulk
Losartan Potassium 100 mg Tablets, Bulk
Methylcobalamin 1000 mcg/ml Solution, 10 mL, Injectable (Compounded)
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable (Compounded)
Hydroxyprogesterone Caproate (BUD) 350mg/ml, 4 mL, Injectable (Compounded)
Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable (Compounded)
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnjectable Solution, 5 mL, Injectable (Compounded)
Nizatidine 15 mg/mL Oral Solution
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/08/2020
Phytonadione 10 mg/mL 1 mL Injectable Emulsion ampule
C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles
C-*Vancomycin Opthalmic 14 mg drops, 5 mL bottle
*Morphine 2 mg/mL Cassette, 100 mL CADD Cassette
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags
*Mitomycin 0.04% Ophthalmic DR eye drops, 5 mL bottle
Gentamicin 80mg/60 mL Irrigation, containers
Glycopyrrolate 1 mg Tablets
Lisinopril 30 mg Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/01/2020
Buprexone Banana cream 6-0.6 mg Troche
Buprenorphine Watermelon 8 mg Troche
Buprenorphine Black Cherry 2 mg Troche
Advil Allergy & Congestion Relief (Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine)10 mg) Tablets
Advil Liquid-Gel Minis (Ibuprofen 200 mg) liquid filled Capsules
Advil Infant Concentrated Drops White Grape (Ibuprofen 50 mg per 1.25 mL) Oral Suspension
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief
Advil Liquid-Gel Mini
Draximage DTPA (Kit for The Preparation of Technetium TC 99M Pentetate Injection), 20 mg Vial
Theophylline (Anhydrous) 400 mg Extended-Release Tablets
Nystatin 100,000 units per mL Oral Suspension, Cherry/Peppermint Flavor
All Ranitidine Products (Zantac)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/26/2020
Phytonadione 10 mg/mL Injectable Emulsion Single-Dose Ampules
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/25/2020
Lisinopril/HCTZ 20mg/12.5mg Tablet
Regular Strength Acid Reducer, Ranitidine 75 mg Tablets, 30 tablets per bottle
Regular Strength Acid Reducer, Ranitidine 75 mg Tablets, 60 tablets per bottle
Regular Strength Acid Reducer, Ranitidine 75 mg Tablets, 80 tablets per bottle
Regular Strength Acid Reducer, Ranitidine 75 mg Tablets, 150 tablets per bottle
Regular Strength Acid Reducer, Ranitidine 75 mg Tablets, 160 tablets per bottle
Maximum Strength Acid Reducer, Ranitidine 150 mg Tablets, 8 tablets
Maximum Strength Acid Reducer, Ranitidine 150 mg Tablets, 24 tablets per bottle
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle
Maximum Strength Acid Reducer, Cool Mint Ranitidine 150 mg Tablets, USP , 40 tablets per bottle
Maximum Strength Acid Reducer, Ranitidine 150 mg Tablets, 50 tablets per bottle
Maximum Strength Acid Reducer, Ranitidine 150 mg Tablets, 65 tablets per bottle
Maximum Strength Acid Reducer, Cool Mint Ranitidine 150 mg Tablets, 65 tablets per bottle
Maximum Strength Acid Reducer, Ranitidine 150 mg Tablets, 90 tablets per bottle
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle
Maximum Strength Acid Reducer, Ranitidine 150 mg Tablets, 95 tablets per bottle
Maximum Strength Acid Reducer, Cool Mint Ranitidine 150 mg Tablets, USP , 95 tablets per bottle
Maximum Strength Acid Reducer, Ranitidine 150 mg Tablets, 200 tablets per bottle
Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr)
Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr)
Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr)
Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr)
Sotalol HCl 80 mg Tablets
Pantoprazole Sodium 40 mg Delayed-Release Tablets
Atorvastatin Calcium 40 mg Tablets
Solifenacin Succinate 5 mg Tablets
Solifenacin Succinate 10 mg Tablets
Doxycycline 75 mg Capsules, 100-count bottle
Doxycycline 100 mg Capsules, 50-count bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/18/2020
Ranitidine 150 mg/10 mL Oral Solution
Ranitidine 150 mg Tablets
Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML)
Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe
Daptomycin, 500 mg in 0.9% NaCl 100 mL Injectable
Ertapenem in 100 mL 0.9% NaCl 1 gram Injectable,
Vancomycin 900 mg in 100 mL 0.9% NaCl Injectable
Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/11/2020
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate 18 mcg/1.8mg/0.2mg/0.02mg/mL Intracavernosal Injection
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate 18 mcg/1.8mg/0.2mg/0.02mg/mL Intracavernosal Injection
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate 40 mcg/25 mg/0.5mg/0.01mg/ml Intracavernosal Injection
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate 60 mcg/30 mg/2 mg/0.15mg/ml Intracavernosal Injection
Alprostadil (prostaglandin E1)150 mcg/ml Intracavernosal Injection
Alprostadil (prostaglandin E1) 80 mcg/ml Intracavernosal Injection
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20mcg/30MG/1MG/ml Intracavernosal Injection
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40mcg/30MG/2MG/ml Intracavernosal Injection
AscorbiX (Buffered C) Injection, Ascorbix (30ml) 500MG/ml Injectable
AscorbiX (Buffered C) Injection, Ascorbix (50ml) 500MG/ml Injectable
B-Complex 110 Injectable
Betamethasone Acetate/Betamethasone (Preservative free) Injectable Suspension, Betamethasone Acetate/Betamethasone (Preservative free) CMC [2ml] 6mg/ml Injectable Suspension
Betamethasone Acetate/Betamethasone (Preservative free) Injectable Suspension, Betamethasone Acetate/Betamethasone (Preservative free) CMC [10ml] 7mg/ml Injectable Suspension
Betamethasone Acetate/Betamethasone (Preservative free) Injectable Suspension, Betamethasone Acetate/Betamethasone (Preservative free) CMC [5ml] 7mg/ml Injectable Suspension
Biotin (Vitamin H) Injectable Suspension, Biotin 10 mg/ml Injection Suspension
Calcium Chloride Injection
Coenzyme Q10 Injection, Coenzyme Q-10 20 mg/ml Oil Injection Solution
Cyanocobalamin Injection, Cyanocobalamin 2000 mcg/ml Injectable
Cyanocobalamin/Folinic Acid Injection, Cyanocobalamin : Folinic Acid 2000 mcg/ml: 500 mcg/ml Injectable
Deoxycholic Acid Sodium Injection, Deoxycholic Acid Sodium 1.67% Injectable
Dexamethasone (La) Injectable Suspension, Dexamethasone La [10ml] 16mg Injection Suspension
Dexpanthenol Injection, Dexpanthenol 250 mg/ml injectable
Glutathione Injection, Glutathione 200 mg/ml Injectable
Glycerin (Preservative free) Injection, Glycerin 99% Injectable
Glycine Injection, Glycine 50 mg/ml Injectable
Human Chorionic Gonadotropin (HCG) Injection, HCG [10ml] 1000 IU/ml Injectable
Hydroxocobalamin Injection, Hydroxocobalamin 5 mg/ml Injectable
Hydroxyprogesterone Caproate Injection, Hydroxyprogesterone Caproate [4ml] 250 mg/ml Injectable
Arginine Hydrochloride Injection, L-Arginine HCl 100 mg/ml Injectable
Polyoxyl Lauryl Ether (Polidocanol) Injection, Laureth-9 (Polidocanol) 5% Injectable
Levocarnitine Injection, Levocarnitine 500 mg/ml Injectable
Lidocaine HCl (Preservative free) Injection, Lidocaine HCl 4% (Preservative free) 40 mg/ml Ocular injection
Lysine Hydrochloride Injection, Lysine HCl 100 mg/ml Injectable
Methionine/Inositol/Choline Injection, Methionine/Inositol/Choline 25mg/50mg/50mg/ml Injectable
Methylcobalamin Injection, Methylcobalamin [CD] 10mg/100mg/ml Injectable
Methylcobalamin Injection, Methylcobalamin 1 mg/ml Injectable
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, Methylprednisolone Acetate/Bupivacaine [10ml] CMC 40mg/5mg/ml Injection Suspension
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, Methylprednisolone Acetate/Bupivacaine [10ml] CMC 80mg/5mg/ml Injection Suspension
Methylprednisolone Acetate Injectable Suspension, Methylprednisolone Acetate (Preservative free) CMC [2ml] 80 mg/ml Injection Suspension
Methylprednisolone Acetate Injectable Suspension, Methylprednisolone Acetate [10ml] CMC 100 mg/ml Injection Suspension
Methylprednisolone Acetate Injectable Suspension, Methylprednisolone Acetate [10ml] CMC 50 mg/ml Injection Suspension
MIC-B12 Injection, MIC-B12 25mg/50mg/50mg/1mg/ml Injectable
MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ml Injectable
MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ml Injectable
Mitomycin-C (Preservative free) Irrigation Solution, MITOMYCIN-C (Preservative free) 0.5 MG/ml Preservative Free Syringe, For Intravesicular
Nicotinamide Adenine Dinucleotide (Preservative free) Injection, Nicotinamide Adenine Dinucleotide (Preservative free) 50 mg/ml Injectable
Nicotinamide Adenine Dinucleotide (Preservative free) Injection, Nicotinamide Adenine Dinucleotide (Preservative free) 20 mg/ml Injectable
Iohexol (Preservative free) Injection, Omnipaque Injection [5ml] 300 mg/ml Injectable
Pyridoxine Hydrochloride Injection, Pyridoxine HCl 100 MG/ml Injectable
Selenium Injection, Selenium 200 mcg/ml Injectable
Super MIC Injection, Super MIC* Injectable, Vitamin Complex
Testosterone Cypionate Injection, Testosterone Cypionate in grapeseed oil [10 ml] 200 MG/ml Injectable
Testosterone Cypionate Injection, Testosterone Cypionate in grapeseed oil [1 ml] 200 MG/ml Injectable
Testosterone Cypionate/Progesterone Injection, Testosterone Cypionate/Progesterone [2ml] 200mg/2.5mg/ml Injectable
Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, Triamcinolone Acetonide/Bupivacaine HCl [10ml] 40mg/5mg/ml Injection Suspension
Triamcinolone Acetonide (Preservative free) Injectable Suspension, Triamcinolone Acetonide (Preservative free) [2ml] 40mg/ml Injection Suspension
Triamcinolone Acetonide (Preservative free) Injectable Suspension, Triamcinolone Acetonide (Preservative free) [10ml] 50 mg/ml Injection Suspension
Triamcinolone Diacetate Injectable Suspension, Triamcinolone Diacetate [10ml] CMC 10 mg/ml Injection Suspension
Triamcinolone Diacetate Injectable Suspension, Triamcinolone Diacetate (Preservative free) [2ml] CMC 40 mg/ml Injection Suspension
Triamcinolone Diacetate Injectable Suspension, Triamcinolone Diacetate [10ml] CMC 80 mg/ml Injection Suspension
Cholecalciferol (Vitamin D3) Injection, Vitamin D3 [P] 1,000 IU/ml Injectable
Cholecalciferol (Vitamin D3) Injection, Vitamin D3 [P] 100,000 IU/ml Injectable
Zinc Chloride Injection, Zinc Chloride 10 mg/ml Injectable
Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone
Mesalamine 1.2 gram Delayed-Release Tablets
Elelyso (taliglucerase alfa) 200 units/vials
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/05/2020
Ketorolac Tromethamine 30mg/ml Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/04/2020
Phenytoin 125 mg/5 mL Oral Suspension
All Montelukast generics
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/26/2020
Phenytoin Oral Suspension, 125 mg/5 mL
Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards)
Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards)
Glycopyrrolate Tabs, 1 mg, 30-count unit dose blister card
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/19/2020
Lamotrigine Tablets, 100 mg, 100-count bottle
Methylphenidate hydrochloride Extended-Release Tablets USP (CII), 18 mg, 100-count bottle
Methylphenidate hydrochloride Extended-Release Tablets USP (CII), 27 mg, 100-count bottle
Fentanyl Citrate Injection, 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use
Ethacrynate Sodium for Injection, 50mg/vial, Single Dose Vial
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg, 30-count bottle,
Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg, 30-count bottle
Hydrocortisone and Acetic Acid Otic Solution, 10 mL dropper bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/12/2020
Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle
Ranitidine Hydrochloride (powder), 1 gram, 5 grams, 25 grams, 100 grams, 500 grams, 1 Kilogram
Atorvastatin Calcium Tablets, 10 mg, 90-count bottle
Olmesartan Medoxomil Tablets 20 mg, 90 Tablets per Bottle
Ranitidine Hydrochloride, 150 mg tablets, 14, 30, 60, 90, 100-count bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/05/2020
DHEA/Pregnenol One 10.25 MG Cap, Compounded Product
Finasteride/Biotin 1 mg/50 mcg, Compounded Product
Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars, Compounded Product
Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars, Compounded Product
Liothyronine (T3) 80 mcg SR cap, Compounded Product
Liothyronine (T3) 92.5 MCG, Compounded Product
Magic Bullet Supplement, Compounded Product
Naltrexone 4.5 mg capsule, Compounded Product
Progesterone 200 mg Troche, Compounded Product
Progesterone 50 mg capsules, Compounded Product
Progesterone E4M SR 100 mg capsules, Compounded Product
Sildenafil 200 mg Troche (Clinic), Compounded Product
Sildenafil 80 mg capsules, Compounded Product
Squaric Acid 0.1% Topical Solution (Clinic) 30 mL, Compounded Product
T3/T4 SR 9 mcg/38 mcg capsule, Compounded Product
Tadalafil 20 mg Troche, Compounded Product
Tadalafil 6 mg Capsule, Compounded Product
Testosterone Topical Cream 4%, Compounded Product
Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Compounded Product
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/29/2020
Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles
Nizatidine Capsules, USP 150 mg
Nizatidine Capsules, USP 300 mg
Ranitidine 150 mg Tablets, 7, 14, 20, 30, 60-count bottles
Ranitidine Tablets USP 150 mg, 4, 20, 24, 30, 90-count bottles
Ranitidine Tablets USP 300 mg, 15, 90-count bottles
Ranitidine Tablets, 150 mg, 30, 60, 90, 100-count bottles
Ranitidine Tablets 300 mg, 14, 30, 90, 100-count bottles
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only
Ranitidine 150 mg tablet
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/22/2020
Alprostadil 40 mcg/ml (2 ml vial) Injectable. Soln. in 2 ml vials Assurance Infusion
Autologous Serum 20% Eye Drops in 3 ml droppers Assurance Infusion
BAC 150 mcg/Buprenorphine 2 mg/HydroMorphone 15 mg/Morphine 20 mg/SUF 650 mcg/ml Injectable. in 20 ml syringe Assurance Infusion
BAC 15mcg/HydroMorphone 15mg/ml Injectable in 20 ml syringe Assurance Infusion
BAC 160mcg/HydroMorphone 16mg/ml Injectable in 20 ml syringe Assurance Infusion
BAC 200mcg/ ClonidineI 250mcg/ Morphine 10mg/ml Injectable in 20 ml syringe Assurance Infusion
BAC 200mcg/Buprenorphine22mg/Clonidine210mcg/HydroMorphone 15mg/SUF800mcg/ml ml Injectable in 20 ml syringe Assurance Infusion
BAC 225mcg/ Buprenorphine 4.5mg/ Clonidine 9mcg/ Morphine 3mg/ml ml Injectable in 20 ml syringe Assurance Infusion
BAC 2400mcg/ Fentanyl 2600mcg/ Morphine 3600mcg/ml Injectable in 20 ml syringe Assurance Infusion
BAC 250mcg/ /Fentanyl 3500mcg/ /Morphine 25mg/ml Injectable in 20 ml syringe Assurance Infusion
BAC 4000mcg /Fentanyl 600mcg/ml Injectable in 20 ml syringe Assurance Infusion
BAC 400mcg/Buprenorphine 20mg/HydroMorphone 15mg/SUF 1000mcg/ml Injectable in 20 ml syringe Assurance Infusion
BAC 50mcg/ HydroMorphone 10mg/ml Injectable in 20 ml syringe Assurance Infusion
BAC 800mcg/Buprenorphine 6.7mg/Clonidine 600 mcg/Fentanyl 850mcg/Morphine 20mg Injectable in 20 ml syringe Assurance Infusion
Baclofen 2000mcg/ml (40) Injectable in 20 ml syringe Assurance Infusion
Bi-Mix 30 mg/1 mg/ml Injectable. in 1 ml vials Assurance Infusion
Bi-Mix Forte 30 mg/2 mg/ml Injectable. in 1 ml vials Assurance Infusion
BPC-157 2000 mcg/ml in 5 ml vials Assurance Infusion
Buprenorphine 10mg/ Fentanyl 1000mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 10mg/HydroMorphone 10mg/Morphine 2mg/SUF 250mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 10mg/HydroMorphone 15mg/SUF 200mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 15mg/Clonidine 300mcg/ Fentanyl 1500mcg/ml(40) Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 15mg/Clonidine 400mcg/ Fentanyl 6000mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 15mg/Clonidine 600mcg/Morphine 30mg/ml (40) Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 15mg/HydroMorphone 5mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 17mg/Morphine 22mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 1mg//ml/HydroMorphone 7mg Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 2.5mg/ ClonidineI 5mcg/ Fentanyl 200mcg/ SUF 50mcg/ml (40) Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 2.5mg/Fentanyl 25mcg/HydroMorphone 2mg/Morphine 40mg/ml in 20 ml syringe Assurance Infusion
Buprenorphine 20mg/Clonidine 250mcg/Fentanyl 7200mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 20mg/Clonidine 300mcg/Fentanyl 2000mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 20mg/SUF 1000mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 20mg/SUF 105mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 21mg/Clonidine 252mcg/Morphine 20mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 23mg/HydroMorphone 25mg/SUF 100mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 2mg/ HydroMorphone 2mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 3.5mg/ HydroMorphone 4mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 30mg/ Fentanyl 400mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 30mg/ HydroMorphone 10mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 30mg/ Morphine 8mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 30mg/Fentanyl 750mcg/HydroMorphone 15mg/ml (40) Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 35mg/Fentanyl 1.5mg/ml in 20 ml syringe Assurance Infusion
Buprenorphine 35mg/Morphine 10mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 3mg/HydroMorphone 15mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 3 mg/Morphine 15 mg/ml Injectable. in 20 ml syringe Assurance Infusion
Buprenorphine 40mg/Fentanyl 1200mcg/SUF 400mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 40mg/Fentanyl 3000mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 40mg/Morphine 4mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 4mg/Fentanyl 3000mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 5.3mg/ Fentanyl 1050 mcg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 5mg/ HydroMorphone 15mg/ SUF 600mcg/ml (40ml) Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 5mg/HydroMorphone 5mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 5mg/Morphine 10mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 5mg/Morphine 20mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 675mcg/Morphine 20mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 7mg/HydroMorphone 20mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 8mg/Clonidine 100mcg/HydroMorphone 20mg/ml Injectable in 20 ml syringe Assurance Infusion
Buprenorphine 9mg/ HydroMorphone 25mg/ SUF 110mcg/ml Injectable in 20 ml syringe Assurance Infusion
CJC-1295 2000 mcg/Ipamorelin 2000 mcg/ml Injectable. in 2 ml vial Assurance Infusion
Clonidine 100mcg/Morphine 12mg/ml Injectable in 20 ml syringe Assurance Infusion
Clonidine 300mcg/Morphine 10mg/ml Injectable in 20 ml syringe Assurance Infusion
Clonidine 500mcg/HydroMorphone 5mg/ml Injectable in 20 ml syringe Assurance Infusion
Clonidine 750mcg/Morphine 30mg/SUF 37.5mcg/ml in 20 ml syringe Assurance Infusion
Clonidine 800mcg/Fentanyl 2000mcg/ml Injectable in 20 ml syringe Assurance Infusion
Fentanyl 600mcg/ SUF 800mcg/ml Injectable in 20 ml syringe Assurance Infusion
Fentanyl 900mcg/SUF 210mcg/ml Injectable in 20 ml syringe Assurance Infusion
Fentanyl 3000mcg/ml Injectable in 20 ml syringe Assurance Infusion
Fentanyl 1000mcg/ml Injectable in 20 ml syringe Assurance Infusion
Fentanyl 100mcg/ml Injectable in 20 ml syringe Assurance Infusion
Fentanyl 2000mcg/ml Injectable in 20 ml syringe Assurance Infusion
Fentanyl 5mg/ml Injectable in 20 ml syringe Assurance Infusion
Fentanyl800mcg/ml Injectable in 20 ml syringe Assurance Infusion
Human Chorionic Gonadotropin (HCG) 1,000U/1ml Injectable in 4 ml vial Assurance Infusion
Human Chorionic Gonadotropin (HCG) 10,000U/1ml Injectable in 4 ml vial Assurance Infusion
Human Chorionic Gonadotropin (HCG) 3000U/1ml Injectable in 4 ml vial Assurance Infusion
HydroMorphone 10mg/SUF 200mcg/ml Injectable in 20 ml syringe Assurance Infusion
HydroMorphone 17mg/PRIALT 5mcg/ml Injectable in 20 ml syringe Assurance Infusion
HydroMorphone 1mg/Morphine 20mg/SUF 100mcg/ml Injectable in 20 ml syringe Assurance Infusion
HydroMorphone 15mg/ml Injectable in 20 ml syringe Assurance Infusion
HydroMorphone 1mg/ml Injectable in 20 ml syringe Assurance Infusion
HydroMorphone 20mg/ml Injectable in 20 ml syringe Assurance Infusion
HydroMorphone 2mg/ml Injectable in 20 ml syringe Assurance Infusion
HydroMorphone 3mg/ml Injectable in 20 ml syringe Assurance Infusion
HydroMorphone 4mg/ml Injectable in 20 ml syringe Assurance Infusion
HydroMorphone 5mg/ml Injectable in 20 ml syringe Assurance Infusion
HydroMorphone 6mg/ml Injectable in 20 ml syringe Assurance Infusion
Ipamorelin 2000mcg/ml Injectable in 2 ml vial Assurance Infusion
LIPO B 25mg/50mg/50mg/1000mcg/ml (10ml VIAL) in 20 ml syringe and 10 ml vial Assurance Infusion
Morphine 20mg/SUF 70mcg/ml Injectable in 20 ml syringe Assurance Infusion
Morphine 10mg/ml Injectable in 20 ml syringe Assurance Infusion
Morphine 15mg/ml Injectable in 20 ml syringe Assurance Infusion
Morphine 18mg/ml Injectable in 20 ml syringe Assurance Infusion
Morphine 1mg/ml Injectable in 20 ml syringe Assurance Infusion
Morphine 20mg/ml Injectable in 20 ml syringe Assurance Infusion
Morphine 2mg/ml Injectable in 20 ml syringe Assurance Infusion
Morphine 30mg/ml Injectable in 20 ml syringe Assurance Infusion
Morphine 4mg/ml Injectable in 20ml syringe Assurance Infusion
Morphine 5mg/ml Injectable in 20 ml syringe Assurance Infusion
Morphine 6mg/ml Injectable in 20 ml syringe Assurance Infusion
Morphine 7mg/ml Injectable in 20 ml syringe Assurance Infusion
Phenol 2.5% STERILE SOLUTION in 50 ml syringe Assurance Infusion
QuadMix in 1 ml vial Assurance Infusion
QuadMix 30mg/2mg/20mcg/100mcg/ml Injectable in 1 ml vial Assurance Infusion
QuadMix Forte in 1 ml vial Assurance Infusion
QuadMix Forte 30mg/4mg/40mcg/400mcg/ml Injectable in 1 ml vial Assurance Infusion
Sufentanil 150mcg/ml Injectable in 20 ml syringe Assurance Infusion
Sufentanil 300mcg/ml Injectable in 20 ml syringe Assurance Infusion
Sufentanil 55.5 mcg/ml IN 18ml Injectable in 18 ml syringe Assurance Infusion
Testosterone Cypionate 200mg/ml OIL in 10 ml vial Assurance Infusion
Testosterone Cypionate 200mg/ml OIL (SESAME) Injectable in 10 ml vial Assurance Infusion
Testosterone Cypionate 200mg/ml OIL Injectable in 10 ml vial Assurance Infusion
TriMix 30mg/1mg/10mcg/ml Injectable in 5 ml/10 ml vials Assurance Infusion
TriMix (UA) 30mg/1mg/20mcg/ml Injectable in 1 ml vial Assurance Infusion
TriMix -A (UA) 30mg/1mg/5 mcg/ml Injectable in 1 ml vial Assurance Infusion
TriMix Forte 30mg/2mg/20mcg/ml Injectable in 1 ml vial Assurance Infusion
TriMix Forte 4 (UA) 30mg/3mg/30mcg/ml Injectable in 1 ml vial Assurance Infusion
TriMix Forte PLUS 30mg/4mg/40mcg/ml Injectable in 1 ml vial Assurance Infusion
TriMix Super (A) 30mg/2mg/30mcg/ml Injectable in 1 ml vial Assurance Infusion
Sumatriptan Succinate Tablets, 50 mg, packaged in 9 (1x9) Unit-of use blister card, 100 count bottles
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card
Testosterone Cypionate for Injectableection, USP, 1,000 mg/10 ml (100 mg/ml), 10 ml Multiple Dose Vial
Testosterone Cypionate for Injectableection, 2,000 mg/10 ml (200 mg/ml), 1 ml Single Use vial, 10 ml Multiple Dose Vial
Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton
Estriol USP Micronized 100 gm; 1 gm; 1 kg; 25 gm; 500 gm; 5 gm
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/15/2020
Lamotrigine Tablets 100mg, 100-count bottles
Glenmark Ranitidine Tablets 150 mg, 60, 100, 500-Tablets
Glenmark Ranitidine Tablets 300 mg, 30, 100, 250-Tablets
Estriol, USP, (Micronized), 0.06 g
Estriol, USP, (Micronized), 0.12 g
Estriol, USP, (Micronized), 0.24 g
Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg)
Ranitidine 150 mg tablets, 24 count bottles
Ranitidine 150 mg tablets, 130 count bottles
Ranitidine Capsules 300 mg, 30 count bottles
Ranitidine Capsules 150 mg, 60, 500-count bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/08/2020
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Case of 50 cups, Case of 40 cups, Unit Dose Cup
Myorisan (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box
Ranitidine Tablets, USP 150mg, 10,000-count bag
Ranitidine Tablets 150mg 60, 500-count bottles
Ranitidine Tablets 300mg 30-count bottles
Ranitidine Tablets 150mg, 4, 20, 24, 30, 90-count bottles
Ranitidine Tablets 300mg, 15, 90-count bottles
Nizatidine Capsules 150mg, 60-count bottles
Nizatidine Capsules 300mg 30-count bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/01/2020
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in 1 G glass bottles, 5 G glass bottles, 25 G glass bottles, 100 G glass bottles, 500 G glass bottles, and 1 KG plastic bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/26/2019
Levetiracetam Oral Solution 100mg/mL
Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers
Mirtazapine Tablets 7.5 mg Tablet 500-count bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/18/2019
Ranitidine Tablets 150mg, 60, 100, 500-count bottles
Ranitidine Tablets 300mg, 30, 100, 250-count bottles
Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging
Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging
Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging
Baclofen in all strengths, all doses and all packaging
Baclofen and Morphine Sulfate in all strengths, all doses and all packaging
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and all packaging
Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging
Fentanyl Citrate in all strengths, all doses and all packaging
Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging
Hydromorphone HCL in all strengths, all doses and all packaging
Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging
Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging
Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging
Morphine Sulfate in all strengths, all doses and all packaging
Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all packaging
Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging
Clonidine HCL in all strengths, all doses and all packaging
Clonidine HCL and Baclofen in all strengths, all doses and all packaging
Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging
Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard)
Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe
Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging
Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging
Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all doses and all packaging
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging
Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all packaging
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging
Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging
Lidocaine HCl 2% 5 mL, Syringe
Ranitidine Tablets, USP 150 mg, 60, 100, 180, 500, 1000-count bottles
Ranitidine Tablets, USP 300 mg, 30, 100, 250-count bottles
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL)
Ranitidine Tablets, USP 150 mg, 1000-count bottles
Ranitidine Tablets, USP 300 mg, 250-count bottles
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton
25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose
Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle
Memorial Central TPN
Trisodium Citrate 0.5% CRRT SOLUTION
Ranitidine Tablets, USP 150 mg, OTC, 30, 60-count bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/11/2019
Cool Mint Tablets Maximum Strength Zantac 150 mg
Regular Strength Zantac 75 mg
Maximum Strength Zantac 150 mg
Regular Strength Zantac 150 mg
Cool Mint Maximum Strength Zantac 150 mg
Maximum Strength Zantac 150 mg
Regular Strength Zantac 75 mg
Regular Strength Zantac 150 mg
Regular Strength Zantac 75 mg
Regular Strength Zantac 75 mg
Zantac 150 mg
Zantac 75 mg
LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base
Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial)
Fentanyl 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag
Fentanyl 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag
Fentanyl 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD
Fentanyl 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag
Fentanyl 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag
Fentanyl 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free
Fentanyl 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag
Fentanyl 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free
Fentanyl 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free
Fentanyl 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free
Fentanyl 100 mcg/2 mL (50 mcg/mL) Preservative Free
Fentanyl 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free
Fentanyl 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe
Fentanyl 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free
Fentanyl 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe
Fentanyl 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride, 100 mL bag
Fentanyl 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride, 200 mL bag
Fentanyl 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag
Fentanyl 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD
Fentanyl 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag
Fentanyl 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe
Fentanyl 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag
Fentanyl 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free
Fentanyl 2500 mcg/50 mL (50 mcg/mL) 50 mL bag
Fentanyl 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free
Fentanyl 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free
Fentanyl 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free
EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
12/04/2019
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial
DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton
Aurobindo Ranitidine Caspules 150 mg, 60-count bottle
Aurobindo Ranitidine Capsules 300 mg, 30-count bottle
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle
Aurobindo Ranitidine Capsules 150 mg, 500 count bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/27/2019
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm
Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g
Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic Ointment USP, Net Wt. 3.5 g (1/8 oz)
Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.)
Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only
Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g, Manufactured For: Perrigo Minneapolis, MN 55427,
Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g)
Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL
Ocusoft Tears Again Lubricant Eye Drops, 15 mL
iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz)
Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL
ActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment, 5%,
ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ)
ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g)
Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL
Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL
Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile)
Altaire Sterile Eye Wash, 15 mL (1/2 fl oz)
Altaire Sterile Eye Wash, 30 mL (1 fl oz.)
Altaire Sterile Eye Wash, 118 mL (4 fl oz)
Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL
Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL
ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram
OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL
Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL)
OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL)
OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond TX 77406-0429 800-233-5469 Made in USA, Mfg. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931,
OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA,
OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL)
OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL)
OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL
OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA,
Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL
Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz)
Puralube Ophthalmic Ointment, 3.5 gram
Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL,
FreshKote Lubricant Eye Drops, Product Size: 15 mL
Clear Eyes Redness Relief, Product Size: 15 mL
Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz.
Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz.
Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz.
Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.)
Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only
Budesonide 0.4mg, 3ML Vial, For Inhalation Only
Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial
Albuterol 2.5mg / Ipratropium 0.75mg, 2ML Vial
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.5mg, 3ML Vial, For Inhalation Only
Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhalation Only
Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only
Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhalation Only
Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only
Albuterol 2.5mg / Ipratropium 0.75mg/ Triamcinolone 0.5 mg 3ML Vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/20/19
Ranitidine Oral Solution, USP 150 mg/10 mL
Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer, 200 Tablets, 24 Tablets, 95 Tablets, 65 Tablets
Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Twin Pack, Single Pack
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer, 50 tablets, 65 tablets, 95 tablets, 24 tablets
Viatrexx-Connectissue, 10 mL Sterile multi-dose via
Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial
Viatrexx-Ouch, 10 mL Sterile multi-dose vial
Viatrexx-Ithurts, 10 mL Sterile multi-dose vial
Viatrexx-Adipose, 10 mL Sterile multi-dose vial
Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial
Viatrexx-Articula, 10 mL Sterile multi-dose vial
Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial
Viatrexx-Infla, 10 mL Sterile multi-dose vial
Viatrexx-Collagen, 10 mL Sterile multi-dose vial
Viatrexx-Prolo, 10 mL Sterile multi-dose vial
Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial
Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial
Viatrexx-GI, 10 mL Sterile multi-dose vial
Viatrexx-Arthros, 10 mL Sterile multi-dose vial
Viatrexx-Immunexx, 10 mL Sterile multi-dose vial
Viatrexx-Relief +, 10 mL Sterile multi-dose vial
Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial
Viatrexx-Facial, 10 mL Sterile multi-dose vial
Viatrexx-Hair, 10 mL Sterile multi-dose vial
Viatrexx-Neuro, 10 mL Sterile multi-dose vial
Viatrexx-Male+, 10 mL Sterile multi-dose vial
Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules
Novitium Pharma Ranitidine Capsules 150 mg 500 capsules
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules
Novitium Pharma Ranitidine Capsules 300 mg 100 capsules
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154
GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles
GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/13/2019
Ranitidine Capsules 150mg
Ranitidine Capsules 300mg
AHP Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups
Ranitidine Tablets, 150 mg
Ranitidine Tablets, 300 mg
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL
Dr. Reddy's: Ranitidine Capsules 150 mg, 60, 500-count bottles, Rx
Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC
Ranitidine Tablets, USP 150 mg, 24, 65, 95, 200 count bottle, (Walgreens) OTC
Ranitidine Tablets, USP 150 mg, 65, 130, 220 count bottles (Walmart) OTC
Ranitidine Tablets, USP 150 mg, 24, 50 count bottles (Kroger) OTC
Ranitidine Tablets, USP 75 mg, 30, 80, 160 count bottles (CVS) OTC
Ranitidine Tablets, USP 75 mg, 30 count bottles (Kroger)
Ranitidine Tablets 75 mg, 30. 60 count bottles (CDMA) OTC
Ranitidine Tablets, USP 150 mg, 95, 220 count bottles (HCA) OTC
Ranitidine Tablets, USP 150 mg, 24, 95 count bottles (Thirty Madison) OTC
Ranitidine Tablets, USP 75 mg, (GeriCare) OTC
Ranitidine Tablets, USP 150 mg, 40 count bottles, (Target) OTC
Dr. Reddy's Ranitidine Capsules, USP 300 mg, 30, 100 count bottles
Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, (OTC)
Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, (OTC)
Ranitidine Tablets, USP 75 mg, 30, 80-count bottles (Walgreens) OTC
Ranitidine Tablets, USP 150 mg, 24, 50-count bottles (CDMA) OTC
Ranitidine Tablets, USP 150 mg, (GeriCare) OTC
Alprazolam Tablets, USP 0.5 mg, 500-count bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
11/06/2019
Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only
Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL)
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL)
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL)
Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection
Lactated Ringer's Injection, 500 mL Flexible Container
0.9% Sodium Chloride Injection, 250 mL VisIVTM Container
Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection
Lyophilized Sermorelin w/ GHRP2 3 mg For injection
Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection
Prasugrel Tablets 5 mg, 30-count bottles
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton and 18-count Vaginal Inserts (with disposable applicators) per carton
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/30/2019
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/ml
Ranitidine Capsules 150mg, 60 ct bottle
Ranitidine Capsules 150mg, 500 ct bottle
Ranitidine Capsules 300mg, 30 ct bottle
Ranitidine Capsules 300mg, 100 ct bottle
Alprazolam 0.5 mg Tablets, 500 bottle
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/23/2019
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only
Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 20mg, 100-count bottle, RX Only
Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottle
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial
Ranitidine Capsules 150mg, 60 ct bottle
Ranitidine Capsules 150mg, 500 ct bottle
Ranitidine Capsules 300mg, 30 ct bottle
Ranitidine Capsules 300mg, 100 ct bottle
Rantidine Tablets, USP 150mg,190(2x95)Tray (Sam’s Club)
Ranitidine Tablets, USP 150mg, 95 ct bottle (Walgreens)
Ranitidine Tablets, USP 150 mg 220 CT Btl (Walmart)
Ranitidine Tablets, USP 150mg 50ct Btl (Kroger)
Ranitidine Tablets, USP 150mg 24ct Btl (Kroger)
Ranitidne Tablets, USP 150mg 65 Ct Btl (Walgreens)
Ranitidine Tablets, USP 150 TAB 65ct BTL CP32 (Walmart)
Ranitidine Tablets, USP 150 Tab 200Ct Btl (Walgreens)
Ranitidine Tablets, USP 150mg Tabs Btl, 24 (Walgreens)
Ranitidine Tablets, USP 75 TAB 30ct Bottle NG (CVS)
Ranitidine Tablets, USP 75mg Tab 30Ct Btl (Walgreens)
Ranitidine Tablets, USP 75mg Tab 80Ct Btl (Walgreens)
Ranitidine Tablets, USP 75 TAB 80ct Bottle NG (CVS)
Ranitidine Tablets, USP 75 TAB 160ct Bottle NG (CVS)
Ranitidine Tablets, USP 75mg 30ct Btl (Kroger)
Ranitidine Tablets, USP 150 TAB 24ct BTL (CDMA)
Ranitidine Tablets, USP 150 Tablet 130ct Bottle NV (Walmart)
Ranitidine Tablets, USP 150 TAB 50ct BTL (CDMA)
Ranitidine Tablets, USP 75 Tab 60ct Btl (Dr. Reddy’s)
Ranitidine Tablets, USP 75 TAB 60ct BTL (CDMA)
Ranitidine Tablets, USP 75 TAB 30ct BTL (CDMA)
Ranitidine Tablets, USP 150mg Tablets 24ct BTL00 (Dr. Reddy’s)
Ranitidine Tablets, USP 150 Tab 95ct Btl (HCA)
Ranitidine Tablets, USP 150 Tab 220ct Btl (HCA)
Ranitidine Tablets, USP Tab 150mg 40ct Bottle (Target)
Ranitidine Tablets, USP 150 Tab 24ct Btl (Thirty Madison)
Ranitidine Tablets, USP 150 Tab 95ct Btl (Thirty Madison)
Ranitidine Tablets, USP 75mg (GeriCare) All Counts
Ranitidine Tablets, USP 150mg (GeriCare) All Counts
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/16/2019
Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power Injection per carton
Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle
Estradiol tablets, 0.5 mg, 100-count bottles
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only
DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL),
DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) ; b) 1.5 mL Each (20 count)
Rifampin for Injection, USP, 600 mg/vial
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/09/2019
C-Acetylcysteine Ophthalmic 10% Solution, Packaged In A) 5 ML And B) 10 ML Droptainer Bottles
C-Albumin 5% Ophthalmic Solution, 10 ML Droptainer Bottles
C-Atropine Sulfate Ophthalmic 0.01%, 5 ML Droptainer Bottles
C-Atropine Sulfate Ophthalmic 0.02%, 5 ML Droptainer Bottles
C-Calcium Gluconate 1% Injection Solution, 10 ML Vial
C-Cromolyn Sod 20 Mg/2 ML Inhalation Solution, 120 ML In 60 Nebulizer Vials
C-Dexamethasone 24mg/ML Injection Solution, Packaged In 1 ML Single Dose Vials
C-Edetate Disodium 1.5% Ophthalmic Solution, 10 ML Droptainer Bottle
C-Gentamicin 30mg/ML Injection Solution Single-dose-vial, 3 ML Vial
C-Hydroxocobalamin 5 Mg/ML Injection Solution, 1 ML Syringe
C-Hydroxocobalamin 25 Mg/ML Injection Solution, 1 ML Syringe
C-Hydroxyprogesterone Capro 250mg/ML Injection, 5 ML Vial
C-Interferon Alfa2b 1milu/ML Ophthalmic Solution, 3 ML Droptainer Bottle
C-Mb12/Hb12 5mg/5mg/ML Injection Solution, 0.9 ML in A 3 ML Syringe
C-Mb12 Nac 13mg/48mg/ML Injection Solution, 0.29 ML in A 0.3 ML Syringe
C-Methylcobalamin 25mg/ML Injection Pfs, Packaged In 0.3 ML, 0.5 ML, 1 ML, And 3 ML Syringes
C-Papav/Phentol/Pge1 10mg/1mg/10mcg/ML, Packaged In A) 5 ML And B) 10 ML Vials
C-Papav/Phentol/Pge1 10mg/1mg/20mcg/ML, 5 ML Vial
C-Papav/Phentol/Pge1 18mg/0.6mg/5.8mcg/ML, 5 ML Vial
C-Papav/Phentol/Pge1 18mg/0.6mg/5.88mcg/ML, 5 ML Vial
C-Papav/Phentol/Pge1 18mg/0.6mg/11.8mcg/ML, 10 ML Vial
C-Papav/Phentol/Pge1 20mg/2mg/20mcg/ML, Packaged In A) 5 ML And B) 10 ML Vial
C-Papav/Phentol/Pge1 30mg/0.5mg/30mcg/ML, 5 ML Vial
C-Papav/Phentol/Pge1 30mg/1mg/20mcg/ML, 5 ML Vial
C-Papav/Phentol/Pge1 30mg/1mg/30mcg/ML, 5 ML Vial
C-Papav/Phentol/Pge1 30mg/1mg/50mcg/ML, 5 ML Vial
C-Papav/Phentol/Pge1 30mg/2mg/5mcg/ML, 5 ML Vial
C-Papav/Phentol/Pge1 30mg/2mg/20mcg/ML, 5 ML Vial
C-Phenol/Cottonseed Oil Injection 5%, 5 ML Vial
C-Tacrolimus 0.03% Ophthalmic Suspension, 5 ML Droptainer Bottle
C-Urea 40% Bladder Instill, 30 ML Vial
C-Verapamil 2.5mg/ML Injection Solution, 10 ML Vial
Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use
Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use
Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites
Bacteriostatic Water for Injection, 30 mL Vial
Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial
L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL)
L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL)
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe
Fentanyl Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag
Fentanyl Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IV Bag
Fentanyl Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag
Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial
Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL)
GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe
GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe
Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use
Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use
Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use
Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use
Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial
Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use
Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial
Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use
Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe
Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe
Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe
Lidocaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe
Lidocaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe
Lidocaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe
Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose Syringe
Lidocaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose Syringe
Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use
Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL)
Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe
Neostigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe
Neostigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe
Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial
Norepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL)
Norepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL)
Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL)
Oxytocin in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag
Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe
Phenylephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe
Phenylephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection
Phenyephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use
Phenyephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use
Phenyephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use
Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use
Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial)
Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial)
Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use
Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-For SC Use
Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized
Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized
Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL)
Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized
Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized
Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized
Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use
Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only
Succinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection
SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection
SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites)
Vitamin 10 B Lyophilized, Vial, For IM Use,
Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use
Vitamin 5 B, 30 mL Vial For IM Use
Vitamin 9 Lyophilized, Vial For IM Use
Vitamin 9A/B Lyophilized, Vial For IM Use
Vitamin B1/B2/B3/B6/Hydroxocobalamin 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer
L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use
Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use
Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle
Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle
Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
10/02/2019
Losartan Potassium Tablets, USP 50mg, 1000 count
Losartan Potassium Tablets, USP 100mg, 90 count
Losartan Potassium Tablets, USP 100mg, 1000 count
Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count.
Ranitidine 150mg Capsules, 500 Count
Ranitidine 150mg Capsules, 500 Count
Ranitidine 150mg Capsules, 500 Count
Ranitidine 150mg Capsules, 500 Count
Ranitidine 150mg Capsules, 60 Count
Ranitidine 150mg Capsules, 60 Count
Ranitidine 150mg Capsules, 60 Count
Ranitidine 150mg Capsules, 60 Count
Ranitidine 150mg Capsules, 60 Count
Ranitidine 300mg Capsules, 30 Count
Ranitidine 300mg Capsules, 30 Count
Ranitidine 300mg Capsules, 30 Count
Ranitidine 300mg Capsules, 30 Count
Ranitidine 300mg Capsules, 30 Count
Ranitidine tablets, USP 150mg, 50's Bottle
Ranitidine tablets, USP 150mg, 65's Bottle
Ranitidine tablets, USP 150mg, 95's Bottle
Ranitidine tablets, USP 150mg, 65's Bottle
Ranitidine tablets, USP 150mg, 24's Bottle
Wal-Zan® 150 Ranitidine Tablets, USP 150 mg, 200's Bottle
Ranitidine tablets, USP 150 mg, 24's Bottle
Ranitidine tablets, USP 150mg, 130's Bottle
Wal-Zan® 150 Ranitidine Tablets, Usp 150 Mg, 24's Bottle
Wal-Zan® 75 Ranitidine Tablets, Usp 75 Mg, 30's Bottle
Cool Mint Ranitidine Tablets, Usp 150 Mg, 24's Bottle
Wal-Zan® 150 Ranitidine Tablets, Usp 150 Mg, 65's Bottle
Wal-Zan® 150 Ranitidine Tablets, Usp 150 Mg, 95's Bottle
Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges
Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges
Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges
Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges
Fentanyl Citrate Active Pharmaceutical Ingredient
Cisplatin Active Pharmaceutical Ingredient
Oxaliplatin Active Pharmaceutical Ingredient
Fexofenadine HCl Tablets, 180 mg, Pkg Size 90
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes
Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/25/2019
PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ, 2 OZ, and c) 4 OZ jars, OTC
PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 OZ, 2 OZ, 4 OZ bottles, OTC
Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ, 2 OZ, 4 OZ jars, OTC
Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 OZ, 2 OZ, and 4 OZ bottles, OTC
Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ, 2 OZ, and 4 OZ jars, OTC
Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 OZ, 2 OZ, and 4 OZ bottles, OTC
Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle
Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in 15, 30, 45-count cartons
Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton
Fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in 15, 30-count carton
Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in 15, 30-count cartons
Fexofenadine HCL Tablets USP, 180 mg, 500's Brite Stock
Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles
Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons
Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/18/2019
Bacteriostatic Water for Injection, USP, 30 mL vials
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle
Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only,Rx only
Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only
20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.
10% Acetyl-L-Cysteine Ophthalmic Solutions, 5ml, 10ml, 15 ml, dropper bottles
5% Acetyl-L-Cysteine Ophthalmic Solutions, 5ml, 10ml dropper bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/11/2019
Milk of Magnesia Oral Suspension 2400 mg/30 ml
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
09/04/2019
Bevacizumab 1.25mg/0.05mL 31G Injectable and Bevacizumab 2.5mg/0.1ml Normject TB Injectable
Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial and diluent per kit
Relpax (eletriptan HBr) tablets, 40 mg, [6-count or 12] per carton
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/28/2019
Clear eyes Redness Relief (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in 0.5 FL OZ (15 mL) bottle, 1 FL OZ (30 mL) bottle, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal
Clear eyes Redness Relief (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle
Clear eyes Maximum Itchy Eye Relief (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle
Clear eyes Maximum Redness Relief (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle
Clear eyes Redness Relief (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle
Bexarotene Capsules, 75 mg, 100 capsules per bottle
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/21/2019
Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution
Abraxane 170 MG / 34 ML IVPB; Abraxane 200 MG / 40 ML IVPB;
Abraxane 180 MG / 36 ML IVPB
Adcetris 96 MG/100 ML NS IVPB
Ado-Trastuzumab 210 MG/250 ml NS;
Ado-Trastuzumab E 213 MG / 250 ML NS;
Ado-Trastuzumab 242 MG/250 ml NS;
Ado-Trastuzumab EMT 168 mg / 250 ml NS;
Ado-Trastuzumab E 160 MG / 250 ML NS;
Ado-Trastuzumab 150 mg / 250 ml NS;
Ado-Trastuzumab EMT 301 mg / 250 ml NS;
Ado-Trastuzumab Emtansine 230mg/250ml NS IV
Alimta 785 mg QS 100 ml 0.9% NaCl IVPB;
Alimta 1000 mg QS 100 ml 0.9% NaCl IVPB
Atezolizumab 1200 MG / 250 ML 0.9% NaCl
Avastin 630 MG / 100 ML 0.9% NaCl IVPB;
Avastin 2.5 mg/ 0.1ML Syringe;
Avastin 587.5 MG/100 ML 0.9% NaCl IVPB;
Avastin 350 MG/100 ML 0.9% NaCl IVPB;
Avastin 325 MG / 100 ML 0.9% NaCl IVPB;
Avastin 3.75 mg/ 0.15 ML Syringe;
Avastin 416 MG / 100 ML 0.9% NaCl IVPB;
Avastin 360 MG/100 ML 0.9% NaCl IVPB;
Avastin 250 MG / 100 ML 0.9% NaCl IVPB;
Avastin 693.125 MG/100 ML 0.9% NaCl IVPB;
Avastin 1020 MG/100 ML NS IVPB;
Avastin 811.875 MG/100 ML 0.9% NaCl IVPB;
Avastin 1006.25 MG/100 ML NS IVPB
Azacitidine 125 MG / 5 ML SUB-Q Syringe;
Azacitidine 75 MG (3 ML) Syringe;
Azacitidine 135 MG / 5.4 ML SUB-Q Syringe
Bevacizumab 784 MG / 100 ML NS IVPB;
Bevacizumab 350 MG/100 ml NS IVPB;
Bevacizumab 425 MG/ 100 ml NS IVPB;
Bevacizumab 420 MG/100 ml 0.9% NaCl IVPB;
Bevacizumab 556 mg/100 ml NS IVPB
Bevacizumab 330 MG / 100 ML NS IVPB;
Bevacizumab 790 MG / 100 ML NS IVPB;
Bevacizumab 470 MG / 100 ML NS IVPB;
Bevacizumab 758 MG / 100 ML NS IVPB;
Bevacizumab 690 MG / 100 ML NS IVPB;
Bevacizumab 599 MG/100 ml NS IVPB;
Bevacizumab 1113 MG / 100 ML NS IVPB;
Bevacizumab 660 MG /100 ml NS IVPB;
Bevacizumab 590 MG / 100 ML NS IVPB;
Bevacizumab 620 MG / 100 ML NS IVPB;
Bevacizumab 800 MG / 100 ML NS IVPB
Bleomycin 18 UNITS / 100 ML NS IVPB
Bortezomib 2.5 mg / 1 ML SQ Syringe;
Bortezomib 2.88 MG / 1.15 ML SQ Syringe;
Bortezomib 2.31 MG / 0.92 ml SQ Syringe;
Bortezomib 2.7 mg / 1.08 ML SQ Syringe;
Bortezomib 1.45 mg / 0.58 ml SQ Syringe;
Bortezomib 2.25 mg (0.9 ML) SQ Syringe;
Bortezomib 1.98 mg / 0.79 ml SQ Syringe
Calcium Gluconate 1 GM /100 ML NaCl 0.9% IVPB
Carboplatin 174 MG / 250ml NS IVPB;
Carboplatin 240 MG / 250 ML NS IVPB;
Carboplatin 750 MG / 250 ML NaCl 0.9% IVPB;
Carboplatin 895 MG / 250 ML NaCl 0.9% IVPB;
Carboplatin 235 MG / 250ml NS IVPB;
Carboplatin 716 MG / 250 ML D5W IVPB;
Carboplatin 400 MG / 500 ML NS IVPB;
Carboplatin 500 MG / 100 ML NaCl 0.9% IVPB;
Carboplatin 575 MG / 500 ML NS IVPB;
Carboplatin 307 MG / 100 ML NaCl 0.9% IVPB;
Carboplatin 766 MG / 500 ML NS IVPB;
Carboplatin 684 / 250 ML NaCl 0.9% IVPB;
Carboplatin 260 MG / 100 ML D5W IVPB
Carboplatin 360 MG /100 ML NaCl 0.9% IVPB;
Carboplatin 274 MG / 250 ML D5W IVPB;
Carboplatin 240 MG / 100 ML D5W IVPB;
Carboplatin 750 MG / 250 ML NS IVPB;
Carboplatin 260 MG / 250 ML NS IVPB;
Carboplatin 460 MG / 250 ML NS IVPB;
Carboplatin 175 MG / 250 ML NS IVPB;
Carboplatin 229.4 MG / 500 ML NS IVPB;
Carboplatin 780 MG / 100 ML NaCl 0.9% IVPB;
Carboplatin 140 MG / 250 ML NS IVPB;
Carboplatin 408 MG / 500 ML NS IVPB;
Carboplatin 847 MG / 250 ML D5W IVPB;
Carboplatin 560 MG / 250 ML D5W IVPB;
Carboplatin 180 MG / 250 ML NS IVPB;
Carboplatin 200 MG / 250 ML D5W IVPB;
Carboplatin 238 MG / 500 ML NS IVPB
Carfilzomib 65 MG IN 50 ML D5W IVPB;
Carfilzomib 75 MG IN 50 ML D5W IVPB;
Carfilzomib 50 MG IN 50 ML D5W IVPB;
Carfilzomib 45 MG IN 50 ML D5W IVPB;
Carfilzomib 46.2 MG IN 50 ML D5W IVPB
Cetuximab 335 MG / 167.5 ML IVPB
Cisplatin 40 MG / 500 ml NS IVPB with Mannitol 40 G;
Cisplatin 80 MG / 250 ml 0.9% NaCl;
Cisplatin 44 MG QS 500 ml NS IVPB;
Cisplatin 40 MG / 500 ml 0.9% NaCl;
Cisplatin 36 MG / 500 ML NS IVPB;
Cisplatin 73 MG QS 500 ml 0.9% NaCl with Mannitol 12.5 G;
Cisplatin 70 MG / 500 ml NS with Magnesium 1 G and Mannitol 12.5 G;
Cisplatin 60 MG /250 ml 0.9% NaCl;
Cisplatin 47 MG /250 ml 0.9% NaCl with Mannitol 12.5 G;
Cisplatin 150 MG / 250 ml 0.9% NaCl;
Cisplatin 115 MG /250 ml NS IVPB;
Cisplatin 80 MG QS 500 ml NS IVPB with Mannitol 12.5 G;
Cisplatin 120 MG / 500 ML NS IVPB;
Cisplatin 157 MG /250 ml 0.9% NaCl with Mannitol 12.5 G;
Cisplatin 43 MG QS 1000 ml 0.9% NaCl with Mannitol 12.5 G
Cisplatin 40 MG / 500 ml NS IVPB with Mannitol 40 G;
Cisplatin 80 MG / 250 ml 0.9% NaCl;
Cisplatin 44 MG QS 500 ml NS IVPB;
Cisplatin 40 MG / 500 ml 0.9% NaCl;
Cisplatin 36 MG / 500 ML NS IVPB;
Cisplatin 73 MG QS 500 ml 0.9% NaCl with Mannitol 12.5 G;
Cisplatin 70 MG / 500 ml NS with Magnesium 1 G and Mannitol 12.5 G;
Cisplatin 60 MG /250 ml 0.9% NaCl;
Cisplatin 47 MG /250 ml 0.9% NaCl with Mannitol 12.5 G;
Cisplatin 150 MG / 250 ml 0.9% NaCl;
Cisplatin 115 MG /250 ml NS IVPB;
Cisplatin 80 MG QS 500 ml NS IVPB with Mannitol 12.5 G;
Cisplatin 120 MG / 500 ML NS IVPB;
Cisplatin 157 MG /250 ml 0.9% NaCl with Mannitol 12.5 G;
Cisplatin 43 MG QS 1000 ml 0.9% NaCl with Mannitol 12.5 G
Cyclophosphamide 840 MG / 250 ML NS IVPB;
Cyclophosphamide 1112 MG / 250 ML NS IVPB;
Cyclophosphamide 1248 MG / 50 ML NS IVPB;
Cyclophosphamide 1125 MG / 100 ML NS IVPB;
Cyclophosphamide 1000 MG / 500 ML NS IVPB;
Cyclophosphamide 1400 MG / 100 ML NS IVPB;
Cyclophosphamide 1056 MG / 250 ML NS IVPB;
Cyclophosphamide 980 MG / 500 ML NS IVPB;
Cyclophosphamide 580 mg / 500 ML NS IVPB;
Cyclophosphamide 880 MG / 500 ML NS IVPB;
Cyclophosphamide 501 MG / 250 ML NS IVPB;
Cyclophosphamide 1163 MG / 50 ML NS IVPB;
Cyclophosphamide 1100 MG / 500 ML NS IVPB;
Cyclophosphamide 1152 MG / 250 ML NS IVPB;
Cyclophosphamide 1116 MG / 250 ML NS IVPB;
Cyclophosphamide 894 MG / 250 ML NS IVPB;
Cyclophosphamide 1210 MG / 500 ML NS IVPB;
Cyclophosphamide 1010 MG/ 500 ML NS IVPB;
Cyclophosphamide 1030 MG / 500 ML NS IVPB;
Cyclophosphamide 500 MG / 250 ML NS IVPB
Cytarabine 128 MG/250 ML D5W IVPB;
Cytarabine 20 MG / 1 ML SQ Syringe;
Cytarabine 70 MG QS 6 ML PF NS Syringe;
Cytarabine 100 MG QS 3 ML PF NS Syringe
Dacarbazine 680 MG in 250 ml NS;
Dacarbazine 675 MG in 250 ml NS
Daratumumab904 MG QS 500 ML NS IVPB;
Daratumumab668 MG QS 1000 ML NS IVPB
Darzalex 1008 MG / 500 ML NS IVPB
Decitabine 40 MG / 100 ml NS IVPB
Dexamethasone 10 MG / 50 ML NS IVPB;
Dexamethasone 5 MG / 50 ML NS;
Dexamethasone 5 MG / 50 ML NS IVPB
Diphenhydramine 25 MG/50 ML NS
Docetaxel 60 MG / 250 ml D5W IVPB;
Docetaxel 71 MG/ 250 ML NS IVPB;
Docetaxel 155 MG/ 250 ml NS IVPB;
Docetaxel 110 mg / 250 ml NS IVPB;
Docetaxel 150 MG / 250 ml NS IVPB;
Docetaxel 137 mg / 250 ml 0.9% NaCl IVPB;
Docetaxel 130 MG/ 250 ml NS IVPB;
Docetaxel 140 MG/ 250 ml NS IVPB;
Docetaxel 144 MG/ 250 ML NS IVPB;
Docetaxel 117 MG/ 250 ML NS IVPB;
Docetaxel 30 mg / 250 ml D5W IVPB;
Docetaxel 125 MG/ 250 ml NS IVPB;
Docetaxel 135 MG / 250 ml NS IVPB
Doxorubicin 110 MG / 55 ML IVP Syringe;
Doxorubicin 56 MG / 28 ML IVP Syringe;
Doxorubicin 75 MG / 37.5 ML IVP Syringe;
Doxorubicin 125 MG / 62.5 ML Syringe IVP;
Doxorubicin 93 MG / 46.5 ML IV Syringe;
Doxorubicin 112 MG / 56 ML IVP Syringe;
Doxorubicin 50 MG / 25 ML IVP Syringe;
Doxorubicin 120 MG / 60 ML IVP Syringe;
Doxorubicin 106 MG / 53 ML IVP Syringe;
Doxorubicin 90 MG / 45 ML IVP Syringe;
Doxorubicin 14 MG/500 ML NS IV with Vincristine 0.7 MG and Etoposide 70 MG;
Doxorubicin 100 MG / 50 ML IVP Syringe;
Doxorubicin 16 MG/1000 ML NS IV with Vincristine 0.6 MG and Etoposide 78 MG;
Doxorubicin 45 MG / 22.5 ML IVP Syringe
Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB;
Doxorubicin Liposomal 66 MG/250 ML D5W;
Doxorubicin 16 MG/1000 ML NS IV with Vincristine 0.6 MG and Etoposide 78 MG
Doxorubicin 16 MG/1000 ML NS IV with Vincristine 0.6 MG and Etoposide 78 MG;
Doxorubicin 45 MG / 22.5 ML IVP Syringe
Durvalumab 651 mg/ 250 ml NS IVPB;
Durvalumab 650 mg/ 250 ml NS IVPB
Entyvio 300 MG /250 ML 0.9% NaCl
Erbitux 770 MG/ 385 ML IVPB;
Erbitux 440 MG/ 220 ml IVPB;
Erbitux 850 MG/ 425 ml IVPB
Eribulin 1.12 MG / 100 ML NS IVPB;
Eribulin 1.87 MG / 100 ML NS IVPB;
Eribulin 1.89 MG / 100 ML NS IVPB
Etoposide 184 MG / 500 ml NS IVPB;
Etoposide 176 MG/ 500 ml 0.9% NaCl IVPB;
Etoposide 170 MG / 500 ml 0.9% NaCl IVPB;
Etoposide 152 MG / 500 ml 0.9% NaCl IVPB;
Etoposide 275 MG / 500 ml NS IVPB;
Etoposide 270 MG / 500 ml NS IVPB;
Etoposide 90 MG / 500 ml NS IVPB;
Etoposide 160 MG / 500 ml NS IVPB;
Etoposide 178 MG/ 500 ml 0.9% NaCl IVPB;
Etoposide 214 MG / 500 ml NS IVPB;
Etoposide 290 MG / 500 ml NS IVPB
Fluorouracil 560 MG / 11.2 ML IVP;
Fluorouracil 3340 MG QS 92 ML 0.9% NaCl;
Fluorouracil 3920 MG QS 92 ML 0.9% NaCl;
Fluorouracil 3760 mg QS 100 ml NS CASS;
Fluorouracil 4000 MG QS 92 ml 0.9% NaCl;
Fluorouracil 3140 MG QS 240 ML NS PUMP;
Fluorouracil 2400 MG QS 96 ML 0.9% NaCl;
Fluorouracil 5000 MG QS 101 ml 0.9% NaCl;
Fluorouracil 750 MG / 15 ML IVP;
Fluorouracil 4500 mg QS 100 ml NS CASS;
Fluorouracil 4100 mg QS 100 ml NS CASS;
Fluorouracil 690 mg / 13.8 ml IVP;
Fluorouracil 2400 MG QS 96 ML NS IV;
Fluorouracil 812 MG/16.24 ML IVP;
Fluorouracil 4872 MG QS 240 ML NS PUMP;
Fluorouracil 4200 mg QS 100 ml NS CASS;
Fluorouracil 1110 MG QS 96 ml NS IVPB;
Fluorouracil 370 MG/ 50 ML NS;
Fluorouracil 620 MG/ 12.4 ML Syringe IVP;
Fluorouracil 3160 MG QS 92 ML 0.9% NaCl;
Fluorouracil 1050 mg QS 92 ml NS IVPB;
Fluorouracil 370 MG /100 ML NS IVPB;
Fluorouracil 4080 MG QS 1000 ML NS IVPB;
Fluorouracil 5 MG / 0.1 ML Syringe;
Fluorouracil 5040 MG QS 101 ml NS CADD;
Fluorouracil 4224 MG QS 100 ml NS CASS;
Fluorouracil 700 MG / 14 ML IVP;
Fluorouracil 3550 mg QS 92 ML 0.9% NaCl IV;
Fluorouracil 760 MG / 15.2 ML IVP;
Fluorouracil 4560 MG QS 240 ML NS PUMP;
Fluorouracil 796 MG / 15.92 MLIVP;
Fluorouracil 4776 MG QS 240 ML NS PUMP;
Fluorouracil 930 MG QS 240 ML NS PUMP;
Fluorouracil 730 MG / 14.6 ML IVP SYR;
Fluorouracil 4400 MG QS 100 ml NS CADD;
Fluorouracil 2430 MG QS 96 ml 0.9% NaCl;
Fluorouracil 4728 MG QS 100 ml NS CASS;
Fluorouracil 3550 MG QS 92 ML 0.9% NaCl;
Fluorouracil 588 MG / 11.76 ML IVP;
Fluorouracil 3528 MG QS 240 ML NS PUMP;
Fluorouracil 2520 mg QS 96 ml NS IVPB;
Fluorouracil 790 MG / 15.8 ml IVP;
Fluorouracil 4750 mg QS 97 ml 0.9% NaCl IV;
Fluorouracil 2660 MG QS 96 ml NS IVPB;
Fluorouracil 720 MG/ 14.4 ML IVP;
Fluorouracil 4370 mg QS 92 ml 0.9% NaCl IV;
Fluorouracil 3280 MG QS 92 ML 0.9% NaCl;
Fluorouracil 780 MG / 15.6 ML IVP;
Fluorouracil 4660 MG QS 97 ml 0.9% NaCl;
Fluorouracil 3620 MG QS 100 ml NS CASS;
Fluorouracil 2370 MG QS 92 ML 0.9% NaCl;
Fluorouracil 800 MG / 16 ML IVP;
Fluorouracil 4800 MG QS 101 ml NS CADD;
Fluorouracil 4000 mg QS 92 ML 0.9% NaCl IV;
Fluorouracil 2480 MG QS 96 ML 0.9% NaCl;
Fluorouracil 688 MG / 13.76 ml IVP;
Fluorouracil 4128 MG QS 1000 ML D5W IVPB;
Fluorouracil 6000 MG QS 250 ml NS CASS;
Fluorouracil 672 MG / 13.44 ML IVP;
Fluorouracil 4032 MG / 1000 ML D5W IVPB;
Fluorouracil 894 MG / 17.88 ml IVP;
Fluorouracil 400 MG / 50 ML NS IVPB;
Fluorouracil 840 MG / 16.8 ml IVP;
Fluorouracil 590 MG/ 11.8 ML IVP
Fosaprepitant150 mg/150 ml NS IVPB
Fluorouracil 560 MG / 11.2 ML IVP;
Fluorouracil 3340 MG QS 92 ML 0.9% NaCl;
Fluorouracil 3920 MG QS 92 ML 0.9% NaCl;
Fluorouracil 3760 mg QS 100 ml NS CASS;
Fluorouracil 4000 MG QS 92 ml 0.9% NaCl;
Fluorouracil 3140 MG QS 240 ML NS PUMP;
Fluorouracil 2400 MG QS 96 ML 0.9% NaCl;
Fluorouracil 5000 MG QS 101 ml 0.9% NaCl;
Fluorouracil 750 MG / 15 ML IVP;
Fluorouracil 4500 mg QS 100 ml NS CASS;
Fluorouracil 4100 mg QS 100 ml NS CASS;
Fluorouracil 690 mg / 13.8 ml IVP;
Fluorouracil 2400 MG QS 96 ML NS IV;
Fluorouracil 812 MG/16.24 ML IVP;
Fluorouracil 4872 MG QS 240 ML NS PUMP;
Fluorouracil 4200 mg QS 100 ml NS CASS;
Fluorouracil 1110 MG QS 96 ml NS IVPB;
Fluorouracil 370 MG/ 50 ML NS;
Fluorouracil 620 MG/ 12.4 ML Syringe IVP;
Fluorouracil 3160 MG QS 92 ML 0.9% NaCl;
Fluorouracil 1050 mg QS 92 ml NS IVPB;
Fluorouracil 370 MG /100 ML NS IVPB;
Fluorouracil 4080 MG QS 1000 ML NS IVPB;
Fluorouracil 5 MG / 0.1 ML Syringe;
Fluorouracil 5040 MG QS 101 ml NS CADD;
Fluorouracil 4224 MG QS 100 ml NS CASS;
Fluorouracil 700 MG / 14 ML IVP;
Fluorouracil 3550 mg QS 92 ML 0.9% NaCl IV;
Fluorouracil 760 MG / 15.2 ML IVP;
Fluorouracil 4560 MG QS 240 ML NS PUMP;
Fluorouracil 796 MG / 15.92 MLIVP;
Fluorouracil 4776 MG QS 240 ML NS PUMP;
Fluorouracil 930 MG QS 240 ML NS PUMP;
Fluorouracil 730 MG / 14.6 ML IVP SYR;
Fluorouracil 4400 MG QS 100 ml NS CADD;
Fluorouracil 2430 MG QS 96 ml 0.9% NaCl;
Fluorouracil 4728 MG QS 100 ml NS CASS;
Fluorouracil 3550 MG QS 92 ML 0.9% NaCl;
Fluorouracil 588 MG / 11.76 ML IVP;
Fluorouracil 3528 MG QS 240 ML NS PUMP;
Fluorouracil 2520 mg QS 96 ml NS IVPB;
Fluorouracil 790 MG / 15.8 ml IVP;
Fluorouracil 4750 mg QS 97 ml 0.9% NaCl IV;
Fluorouracil 2660 MG QS 96 ml NS IVPB;
Fluorouracil 720 MG/ 14.4 ML IVP;
Fluorouracil 4370 mg QS 92 ml 0.9% NaCl IV;
Fluorouracil 3280 MG QS 92 ML 0.9% NaCl;
Fluorouracil 780 MG / 15.6 ML IVP;
Fluorouracil 4660 MG QS 97 ml 0.9% NaCl;
Fluorouracil 3620 MG QS 100 ml NS CASS;
Fluorouracil 2370 MG QS 92 ML 0.9% NaCl;
Fluorouracil 800 MG / 16 ML IVP;
Fluorouracil 4800 MG QS 101 ml NS CADD;
Fluorouracil 4000 mg QS 92 ML 0.9% NaCl IV;
Fluorouracil 2480 MG QS 96 ML 0.9% NaCl;
Fluorouracil 688 MG / 13.76 ml IVP;
Fluorouracil 4128 MG QS 1000 ML D5W IVPB;
Fluorouracil 6000 MG QS 250 ml NS CASS;
Fluorouracil 672 MG / 13.44 ML IVP;
Fluorouracil 4032 MG / 1000 ML D5W IVPB;
Fluorouracil 894 MG / 17.88 ml IVP;
Fluorouracil 400 MG / 50 ML NS IVPB;
Fluorouracil 840 MG / 16.8 ml IVP;
Fluorouracil 590 MG/ 11.8 ML IVP
Gazyva 100 MG IN 250 ML NS IVPB;
Gazyva 900 MG IN 250 ML NS IVPB
Gemcitabine 1910 MG / 250 ML NS IVPB;
Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB;
Gemcitabine 1290 MG /250 ML NS IVPB;
Gemcitabine 460 MG / 250 ML NS IVPB;
Gemcitabine 880 MG / 250 ML NS IVPB;
Gemcitabine 810 MG / 250 ML NS IVPB;
Gemcitabine 820 MG / 250 ML NS IVPB;
Gemcitabine 1748 MG / 250 ML NS IVPB;
Gemcitabine 890 MG /250 ML NS IVPB;
Gemcitabine 2000 MG /250 ML 0.9% NaCl IVPB;
Gemcitabine 660 MG / 250 ML NS IVPB;
Gemcitabine 1880 MG /250 ML NS IVPB;
Gemcitabine 1180 MG / 250 ML NS IVPB;
Gemcitabine 1400 MG / 250 ML NS IVPB;
Gemcitabine 1300 MG / 250 ML NS IVPB;
Gemcitabine 1406 MG /250 ML NS IVPB;
Gemcitabine 1672 MG / 250 ML NS IVPB;
Gemcitabine 2050 MG / 250 ML NS IVPB;
Gemcitabine 1260 MG / 250 ML NS IVPB;
Gemcitabine 1710 MG / 250 ML NS IVPB;
Gemcitabine 1320 MG / 250 ML NS IVPB;
Gemcitabine 1200 MG /250 ML NS IVPB
Granisetron 1000 MCG / 50 ML NS
Herceptin 400 MG / 250 ML NS IVPB;
Herceptin 340 MG /250 ml 0.9% NaCl IVPB;
Herceptin 553 MG / 250 ml NS IVPB;
Herceptin 305 MG / 250 ml NS IVPB;
Herceptin 526 MG / 250 ML NS IVPB;
Herceptin 162 MG / 250 ML NS IVPB;
Herceptin 354 MG/ 250 ml 0.9% NaCl IVPB;
Herceptin 440 MG / 250 ML NS IVPB;
Herceptin 650 MG / 250 ML NS IVPB;
Herceptin 472 MG / 250 ML NS IVPB
Ifosfamide 9200 MG / 1 L NS IVPB with MESNA 9200 MG
Infliximab 300 mg / 250 ml 0.9% NaCl IVPB,
Injectafer 720 MG in 100 ml NS IVPB;
Injectafer 210 MG in 100 ml NS IVPB
Irinotecan 250 MG /500 ml D5W IVPB;
Irinotecan 110 MG /250 ML D5W IVPB;
Irinotecan 250 MG/250 ML NS IVPB;
Irinotecan 315 MG / 250 ML NS IVPB;
Irinotecan 155 MG / 500 ml D5W IVPB;
Irinotecan 75 MG / 250 ML NS IVPB;
Irinotecan 140 MG / 250 ML NS IVPB;
Irinotecan 317 MG /500 ML D5W IVPB;
Irinotecan 135 mg / 500 ml D5W IVPB;
Irinotecan 265 MG / 500 ML D5W IVPB;
Irinotecan 140 MG / 500 ml D5W IVPB;
Irinotecan 195 mg / 500 ml D5W IVPB;
Irinotecan 245 mg / 500 ml D5W IVPB;
Irinotecan 130 MG / 500 ML D5W IVPB
Iron Sucrose 200 mg / 100 ML NS IVPB
Leucovorin 560 MG / 250 ML NS IVPB;
Leucovorin 830 MG / 250 ml NS IVPB;
Leucovorin 300 MG / 50 ml D5W IVPB;
Leucovorin 840 MG / 250 ml NS IVPB;
Leucovorin 750 MG / 250 ml NS IVPB;
Leucovorin 690 MG / 250 ml NS IVPB;
Leucovorin 314 mg / 50 ml NS IVPB;
Leucovorin 620 MG / 250 ml D5W IVPB;
Leucovorin 420 MG / 50 ML D5W IVPB;
Leucovorin 700 MG / 250 ml D5W IVPB;
Leucovorin 592 mg / 250 ml D5W IVPB;
Leucovorin 760 mg / 250 ml D5W IVPB;
Leucovorin 796 MG / 250 ml D5W IVPB;
Leucovorin 730 MG / 250 ml D5W IVPB;
Leucovorin 324 mg / 50 ml NS IVPB;
Leucovorin 590 MG / 250 ml D5W IVPB;
Leucovorin 336 MG / 50 ml NS IVPB;
Leucovorin 398 MG/ 250 ml D5W IVPB;
Leucovorin 354 MG / 50 ml NS IVPB;
Leucovorin 720 MG / 250 ml D5W IVPB;
Leucovorin 328 mg / 50 ml NS IVPB;
Leucovorin 776 MG / 250 ml D5W IVPB;
Leucovorin 339 MG / 250 ml D5W IVPB;
Leucovorin 800 mg / 250 ml D5W IVPB;
Leucovorin 330 MG / 50 ml D5W IVPB;
Leucovorin 330 MG / 50 ml NS IVPB;
Leucovorin 688 MG in 250 ML D5W IVPB;
Leucovorin 350 MG / 250 ml NS IVPB;
Leucovorin 672 MG / 250 ml D5W IVPB;
Leucovorin 588 mg / 250 ml D5W IVPB;
Leucovorin 812 MG / 250 ML D5W IVPB;
Leucovorin 300 MG / 100 ml NS IVPB
Methotrexate 25 MG / 1 ML IM SYR;
Methotrexate 12 mg QS 5 ml PF 0.9% NaCl;
Methotrexate 98 MG / 3.92 ML IM SYR;
Methotrexate 55 MG / 2.2 ML IVP;
Methotrexate 59.5 MG / 2.38 ML IVP;
Methotrexate 12 mg QS 6 ml 0.9% NaCl;
Methotrexate 150 MG / 50 ML NS IVPB;
Methotrexate 112.5 MG/ 4.5 ML IM SYR
Methylprednisolone 10 MG / 0.16 ML IVP
Mitomycin 10 MG /20 ML IVP Syringe
Nivolumab 480 MG / 100 ML NS IVPB;
Nivolumab 200 mg / 100 ML NS IVPB;
Nivolumab 165 mg / 100 ML NS IVPB;
Nivolumab 240 mg / 100 ML NS IVPB
Ondansetron 8 MG / 50 ml NS IVPB
Opdivo 200 mg /100 ML NS IVPB;
Opdivo 480 mg/100 ML NS IVPB
Orencia 750 mg QS 100 ml 0.9% NaCl IVPB
Oxaliplatin 145 MG /250 ML D5W IVPB;
Oxaliplatin 154 MG / 250 ML D5W IVPB;
Oxaliplatin 130 MG / 250 ML D5W IVPB;
Oxaliplatin 140 MG / 250 ml D5W IVPB;
Oxaliplatin 162 MG / 250 ML D5W IVPB;
Oxaliplatin 169 MG / 250 ML D5W IVPB;
Oxaliplatin 90 MG / 500 ML D5W IVPB;
Oxaliplatin 50 MG / 250 ML D5W IVPB;
Oxaliplatin 70 MG / 500 ML D5W IVPB;
Oxaliplatin 40 MG / 250 ML D5W IVPB;
Oxaliplatin 155 MG / 250 ML D5W IVPB;
Oxaliplatin 85 MG / 250 ML D5W IVPB;
Oxaliplatin 146 MG / 250 ML D5W IVPB;
Oxaliplatin 246 MG / 500 ML D5W IVPB;
Oxaliplatin 143 MG / 250 ML D5W IVPB;
Oxaliplatin 65 MG / 500 ML D5W IVPB;
Oxaliplatin 80 MG / 500 ML D5W IVPB;
Oxaliplatin 100 MG / 250 ML D5W IVPB;
Oxaliplatin 150 MG / 250 ML D5W IVPB;
Oxaliplatin 125 MG / 250 ML D5W IVPB;
Oxaliplatin 170 MG / 250 ML D5W IVPB
Paclitaxel 258 MG / 500 ML NS IVPB;
Paclitaxel 318 MG / 500 ML NS IVPB;
Paclitaxel 385 MG / 500 ML NS IVPB;
Paclitaxel 340 MG / 500 ML NS IVPB;
Paclitaxel 332 MG / 500 ML NS IVPB;
Paclitaxel 250 MG / 500 ML NS IVPB;
Paclitaxel 117 MG / 250 ML NaCl 0.9% IVPB;
Paclitaxel 90 MG / 250 ML NS IVPB;
Paclitaxel 290 MG / 500 ML NS IVPB;
Paclitaxel 168 MG / 250 ML NS IVPB;
Paclitaxel 157 MG / 250 ML NS IVPB;
Paclitaxel 350 MG / 500 ML NS IVPB;
Paclitaxel 280 mg / 500 ML NS IVPB;
Paclitaxel 282 mg / 500 ML NS IVPB;
Paclitaxel 90 MG / 250 ML D5W IVPB;
Paclitaxel 255 MG / 500 ML NS IVPB;
Paclitaxel 100 MG / 250 ML NS IVPB;
Paclitaxel 80 MG / 250 ML D5W IVPB;
Paclitaxel 117 MG / 250 ML NS IVPB;
Paclitaxel 159 MG / 250 ML NS IVPB;
Paclitaxel 330 MG / 500 ML NS IVPB;
Paclitaxel 135 MG / 250 ML NS IVPB;
Paclitaxel 200 MG / 500 ML NS IVPB;
Paclitaxel 150 MG / 250 ML NS IVPB;
Paclitaxel 130 MG / 250 ML NS IVPB;
Paclitaxel 144 MG / 250 ML NS IVPB;
Paclitaxel 300 MG / 500 ML NS IVPB;
Paclitaxel 120 MG / 250 ML NS IVPB;
Paclitaxel 140 MG / 250 ML NS IVPB
Paclitaxel Albumin 185 mg /100 ml NS IVPB;
Paclitaxel Albumin 160 MG / 100 ml NS IVPB;
Paclitaxel Albumin 145 MG / 100 ml NS IVPB;
Paclitaxel Albumin 165 mg / 100 ml NS IVPB;
Paclitaxel Albumin 150 mg /100 ml NS IVPB
Paclitaxel Protein 175 MG/100 ML NS IVPB;
Paclitaxel Protein 190 MG/100 ML NS IVPB;
Paclitaxel Protein 355 MG/100 ML NS IVPB
Pembrolizumab 200 MG / 100 ML NS IVPB
Panitumumab 400 MG / 100 ml NS IVPB
Pemetrexed 910 MG QS 100 ML NS IVPB;
Pemetrexed 940 mg QS 100 ml NS IVPB;
Pemetrexed 1000 mg QS 100 ml 0.9% NaCl IVPB;
Pemetrexed 490 MG /100 ml NS IVPB;
Pemetrexed 800 mg/ 100 ml NS IVPB
Perjeta 420 MG/250 ml 0.9% NaCl IVPB
Pertuzumab 840 MG/250 ml0.9% NaCl IVPB
Preservative Free 0.9% NaCl 5 ML SYR
Ramucirumab 457 MG QS 250 ML NS IVPB;
Ramucirumab 1182 MG QS 250 ML NS IVPB
Remicade 680 MG QS 250 ML 0.9% NaCl IVPB;
Remicade 270 MG QS 250 ML 0.9% NaCl IV;
Remicade 730 MG QS 250 ML 0.9% NaCl IVPB;
Remicade 330 MG QS 250 ML 0.9% NaCl IVPB;
Remicade 740 MG IN 250 ML NS IVPB;
Remicade 650 MG / 250 ml 0.9% NaCl;
Remicade 1200 MG/250 ml 0.9% NaCl IVPB;
Remicade 800 MG/250 ml 0.9% NaCl IVPB;
Remicade 600 MG / 250 ml 0.9% NaCl IVPB
Rituxan 728 MG QS 728 mL 0.9% NaCl IVPB;
Rituxan 560 MG / 306 ml 0.9% NaCl;
Rituxan 562 MG IN 562 ml 0.9% NaCl;
Rituxan 700 MG QS 700 mL 0.9% NaCl IVPB;
Rituxan 1000 MG / 350 mL 0.9% NaCl IVPB;
Rituxan 730 MG / 730 mL 0.9% NaCl IVPB;
Rituxan 1000 MG QS 1000 ml NS;
Rituxan 1000 MG QS 200 ml 0.9% NaCl;
Rituxan 500 MG / 300 ml 0.9% NaCl;
Rituxan 660 MG QS 660 ml 0.9% NaCl;
Rituxan 770 MG QS 770 mL 0.9% NaCl IVPB
Rituximab 575 MG / 250 ml 0.9% NaCl IVPB;
Rituximab 675 MG / 250 ml 0.9% NaCl IVPB;
Rituximab 1000 MG / 1000 ml NS IVPB
Romiplostim 700 MCG/ 1.4 ML SQ SYR
Sodium Chloride 0.9% 1 LITER with Potassium Chloride 20 mEq, Mannitol 12.5 G, Magnesium Sulfate 2 G
Soliris 1200 MG QS 240 ML NaCl0.9% IVPB;
Soliris 900 MG QS 180 ML NaCl 0.9% IVPB
Topotecan 1.24 MG / 100 ML NS IVPB
Trastuzumab 427 MG / 250 ml NS IVPB;
Trastuzumab 531 MG / 250 ML NS IVPB;
Trastuzumab 276 MG / 250 ML NS IVPB;
Trastuzumab 360 MG / 250 ML NS IVPB;
Trastuzumab 757 MG / 250 ML NS IVPB;
Trastuzumab 450 MG / 250 ML NS IVPB;
Trastuzumab 120 MG / 250 ML NS IVPB;
Trastuzumab 164 MG / 250 ML NS IVPB;
Trastuzumab 444 MG / 250 ml NS IVPB;
Trastuzumab 634 MG / 250 ML NS IVPB;
Trastuzumab 330 MG / 250 ML NS IVPB;
Trastuzumab 781 MG / 250 ML NS IVPB;
Trastuzumab 376 mg / 250 ML NS IVPB;
Trastuzumab 114 MG / 250 ML NS IVPB;
Trastuzumab 266 MG / 250 ML NS IVPB;
Trastuzumab 323 MG / 250 ML NS IVPB
Velcade 2.1 mg / 0.84 ml SQ Syringe;
Velcade 2.5 MG/ 1 ML SUB-Q Syringe;
Velcade 2.2 MG/ 0.88 ML SUB-Q Syringe;
Velcade 2.6 MG (1.04 ML) Sub Q Syringe;
Velcade 4 mg / 1.6 ml SQ Syringe;
Velcade 2.75 mg / 1.1 ml SQ Syringe;
Velcade 2.6 mg / 1.04 ml SQ Syringe;
Velcade 1.7 mg / 0.68 ml SQ Syringe;
Velcade 3.5 mg / 1.4 ML SQ Syringe;
Velcade 2.2 mg / 0.88 ml SQ Syringe;
Velcade 2.33 MG/ 0.93 ML SUB-Q Syringe;
Velcade 2.4 MG/ 0.96 ML SUB-Q Syringe;
Velcade 2.63 MG/ 1.052 ML SUB-Q Syringe
Vinblastine 10.9 MG / 100 ML D5W IVPB;
Vinblastine 10.8 MG / 100 ML D5W IVPB
Vincristine 1 MG /50 ML NS IVPB;
Vincristine 1.2 MG /50 ML NaCl 0.9% IVPB;
Vincristine 1 MG / 1 ML IVP Syringe;
Vincristine 2 MG /100 ML D5W IVPB
Ferric Carboxymaltose 750mg/50ml NS IVPB
CVS Health Glycerin Suppositories, 50-count box
Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz (99.2 g)
CVS Therapeutic Menthol Gel, 8 FL OZ (227 g)
Children Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-count
Adult Glycerin Suppositories, Package Size 25-count suppositories
Adult Glycerin Suppositories, Package Size 50-count suppositories
Adult Glycerin Suppositories, Package Size 100-count suppositories
Hydrocortisone Cream with Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube
Hydrocortisone Cream with Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56 g) tube
Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube
Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube
Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube
CVS Health Glycerin Suppositories, 100- count box
CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL)
Cool Hot Ice Analgesic Gel, 8 oz (227 g)
Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in 3 OZ./85 g, 4 OZ/ 113 g, 32 OZ/ 907 g, 16 OZ/ 454 g, 128 OZ/ 3629 g
Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in 3 OZ /85 g, 4 OZ / 113 g, 16 OZ / 454 g
CRYO-273 Cold Pain Relieving Gel 128 FL. OZ.
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle
Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle
Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses)
Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/14/19
Ascorbic Acid 500 mg/ml (Non-Corn) Injection (PFV), 50 m per vial
Ascorbic Acid 400 mg/ml (Non-Corn) Injection Solution, 65 mL per vial
Ascorbic Acid 500 mg/ml (Non-Corn) Injection (Multi-dose Vial), 50 mL per vial
Avastin, 25MG/ML Syringe 0.1 mL, 0.12 mL, 0.15 mL
Buffered Lidocaine 1%+EPI 1:100,000 Injection Solution, 3ml and 30ml per Syringe
Buffered Lidocaine HCl 1% Injection Solution (Pf), 10ml per Vial
Buffered Lidocaine HCl 1% Injection Solution (Pf) Syringe, 0.5 ml per Vial
Calcium Chloride 100mg/ml (PFV) Injection Solution, 10 ml per Vial
Calcium Gluconate 5% Injection Solution (MDV), 20 ml per Vial
Copper 0.4mg/ml (PVF) Injection Solution, 10 ml Per Vial
Cyancobalamin 1200mcg/ml MDV Injection, 30 ml Per Vial
Dexpanthenol 250mg/ml (Multi-dose) Injection Solution, 30ml per Vial
Dextrose 50% Injection Solution (PF) Syringe, 50 ml per Syringe
Dextrose 50% Injection Solution (PF) Vial, 50 ml per Vial
Diazepam 5 Mg/ml Injection Solution (C-IV) Syringe, 2 ml per Syringe
Dimercapto-Propanesulfonic 5% (Dmps)(PFV) Injection Sol, 5 ml per Vial
Edetate Calcium Disodium 150mg/ml Injectable, 100 ml per Vial
Edetate Disodium 30% Injectable, 100 ml per Vial
Edetate Disodium 15% Injectable, 30 ml per Vial
Edetate Disodium 15% Injectable, 100 ml per Vial
Edetate Disodium150mg/ml PFV, 10 ml per Vial
Ephedrine 5mg/ml (PF) Syringe, 5 ml per Syringe
Epinephrine 4mg Added to D5w 5%, 250 ml per Bag
Epinephrine 1:1000 Injection Solution (PF) Syringe, 1 ml per Syringe
Fentanyl 0.05mg/ml Injection Sol (PF), 55ml per Syringe (C-II)
Fentanyl 2mcg/ml Bupivacaine 0.125% In NaCl 0.9% Sry C-II, 50ml per Syringe (C-II)
Folic Acid 10mg/ml Injection Solution (Multi-dose), 5 ml per Vial
Folic Acid 5mg/ml Injection Solution (Multi-dose), 10 ml per Vial
Glutathione 200mg/ml (PFV) Injection Solution, 10 ml per Vial
Glutathione 200mg/ml (Multi-dose) Injection Solution, 30 ml per Vial
Hydrogen peroxide 3% Injectable PFV, 30 ml per Vial
Hydromorphone 0.2mg/ml In NaCl 0.9% Syringe (C-Ii), 50 ml, 55 ml
Hydroxocobalamin 1000 Mcg/ml (PFV), 10 ml per Vial
Hydroxocobalamin 1000 Mcg/ml (Multi-dose), 30 ml per Vial
Inositol/Choline B12:B6, 50/50/1/0.175 Mg/ml Injection Solution (Sulfa Free Lipostat), 30 ml per Vial
Ketamine 50 Mg/ml (NPV) Injection Solution (C-Iii), 10 ml per Vial
Ketamine 10 Mg/ml Injection Sol Syringe (C-Iii), 2 ml, 5 ml per Syringe
Lidocaine HCl 1% Injection Solution (NPV), 20ml per Vial
Lidocaine HCl 2% Injection Solution (NPV), 20ml per Vial
Magnesium 200 mg/ml/ Calcium Gluc 6mg/ml/ Zinc 1mg/ml, 5ml per Vial
Magnesium Chloride Hexahydrate (Multi-dose) 20% Injection Solution, 50 ml per Vial
Magnesium Chloride Hexahydrate (PFV) 20% Injection Solution, 50 ml per Vial
Manganese Sulfate Monohydrate (PFV) 0.1mg/ml Injection, 10 ml per Syringe
Methylcobalamin 10mg/ml Injectable Solution (Multi-dose), 10 ml per Vial
Methylcobalamin 1 Mg/ml (Multi-dose) Injectable Solution, 10 ml per Vial
Methylcobalamin (PFV) 10 Mg/ml Injectable, 10 ml per Vial
MIC (Methionine/Inositol/Choline Chloride) 25/50/50 Mg/ml Injection, 30 ml per Vial
MIC B12 W/B6 (Lipostat Plus) 25/50/50/1/.175 Mg/ml, 30 ml per Vial
Midazolam 1mg/ml In NaCl 0.9% Injection Sol Syringe (C-Iv), 10 ml per Syringe
Midazolam 1mg/ml In NaCl 0.9% Injection Syringe C-Iv, 55 ml per Syringe
Mitomycin 0.04% (PF) Ophthalmic Solution, 1ml per Syringe
Molybdenum 0.025mg/ml Injection Solution, 10ml per Vial
Morphine 1mg/ml In NaCl 0.9% 55ml Syringe (C-Ii), 55 ml per Vial
Moxifloxacin 0.5% Ophthalmic Solution Syringe, 1 ml per Syringe
Neostigmine Methyl Sulfate 1mg/ml Injection Sol Syringe, 5 ml per Syringe
Niacinamide 100mg/ml, 10ml per Vial
Ondansetron 2 Mg/ml Injection Solution (NPF), 20ml per Vial
Ondansetron 2 Mg/ml Injection Solution (PFV), 2 ml per Vial
Phenylephrine HCl 100 Mcg/ml In NaCl 0.9% Syringe, 10 ml per Syringe
Pho-Tid-Chol 50mg/ Deoxycholic 42 Mg/ml Injection, 30 ml per Vial
Potassium Chloride 15% (2meq/ml) Injection Solution, 30 ml per Vial
Prednisolone 1%, Moxifloxacin 0.5% Ophthalmic Sol, 5ml per Dropper Bottle
Procaine HCl 20 Mg/ml (Multi-dose) Injectable Solution, 30 ml per Vial
Procaine HCl (PFV) 20 Mg/ml Injectable Solution, 30 ml per Vial
Procaine HCl 8% (PFV) Injectable, 10ml per Vial
Pyridoxine (Multi-dose) 100mg/ml, 30ml per Vial
Pyridoxine (PFV) 100mg/ml, 30ml per Vial
Riboflavin 0.1% Ophthalmic Solution Syringe, 2 ML per Syringe
Ropivicaine 0.2%, Injection Solution, 550 ml On-Q Pump
RXQ Cain (Phenylep 1.5%/ Lido 1% Ophthalmic Sol (PF), 1 ml per Vial, .
Sodium Bicarbonate 8.4% (1 MEQ/ml) Injection Solution (PFV), 50 ml per Vial
Lidocaine 0.75%/Epinephrine 0.025%/BSS 0.56ml Syringe, 1 ml per Syringe
Sod-Phos (Phos 3mmol/ml-Sod 4meq/ml) PFV Injection Solution, 10 ml per Vial
Sterile Water for Injection USP, [10, 30, Or 50 ML] per Vial
Succinylcholine Chloride 20mg/ml Injection Solution, 10 ml per Vial
Taurine 50 Mg/ml (Multi-Dose Vial) Injectable, 30 ml per Vial
Thiamine HCl 100mg/ml (Multi-dose Vial) Injection, 10 ml per Vial
Travasol 10% (Amino Acid) Injection Solution, 50 ml per Vial
Turbo Caine 2.5 (Phen2.5/Cyclo1/ Trop1/Tetra 0.5), 0.4 ml per Syringe
Turbo Drops (Phen 0.625%/Cyclo 0.25%/Trop 0.25%/Keto 0.125%) Ophthalmic Solution, 0.4 ml per Syringe
Turbo Drops (Phen 10% / Cyclo 1%/ Trop 1%/ Keto 0.5%) Ophthalmic Solution, 5 ml per Dropper Bottle
Turbo Drops (Phen 2.5% / Cyclo 1%/ Trop 1%/ Keto 0.5%) Ophthalmic Solution, 5 ml per Dropper Bottle
Vitamin B Complex 100 (Multi-dose Vial), 30 ml per Vial
Vitamin B Complex 100 (PFV), [2 Or 30 ml] per Vial
Zinc Sulfate 1mg/ml Injection Solution (PFV), 10ml per Vial
Zinc Sulfate 1mg/ml Injection Solution, 30ml per Vial
Mometasone Furoate Cream USP, 0.1%, packaged in 15 gram and 45 gram tubes
CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL)
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton
CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
08/07/19
Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL)
Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles
Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles
Acetylcysteine 2% Otic Drop, 15 mL bottle
Alprostadil 100 mcg/mL Injectable, 2.5 mL vial
Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial
Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container
Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal
Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial
Divalproex Sodium Extended-Release Tablets, USP Tablets, 250 mg, 100 count-unit dose carton
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters)
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/31/2019
Gencontuss (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, N/A, 16 fl oz (474 mL) bottle
Double Tussin DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle
LidoAID (Lidocaine HCL 4%) portable pain-relieving Topical Analgesic Gel, 0.17 Oz (4 g) roll on bottle
Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar
Tusslin (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle
Sorbugen NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle
Neogen-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle
Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL)
Ritussin DM Children & Adults, N/A, 4 Fl. Oz. (118 mL)
Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml)
Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL)
Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL)
Ritussin DM Double Strength, 4 FL. OZ. (118 mL)
Gericare Geri-Tussin DM, N/A, 16 FL OZ (473 mL)
Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL
Temozolomide Capsules, 5 mg, 5, 14-count bottle
Temozolomide Capsules, 20 mg, 5, 14-count bottle
Temozolomide Capsules, 100 mg, 5, 14-count bottle
Temozolomide Capsules, 140 mg, 5, 14-count bottle
Temozolomide Capsules, 180 mg, 5, 14-count bottle
Temozolomide Capsules, 250 mg, 5-count bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/24/2019
Fluorouracil Injection, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag
Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag
Kogenate FS antihemophilic factor (recombinant), 2000 IU
Drospirenone and Ethinyl Estradiol Tablets, 3 mg/ 0.02mg, 3x28 tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/17/2019
Losartan Potassium Tablets, 50 mg, 90 Count Bottles, 1000 Count Bottles
Losartan Potassium Tablets, 100 mg, 90 Count Bottles
Losartan Potassium 50 mg Tablet, 90 Tablets
Losartan Potassium Tablet, 50 mg, 1000 Tablets
Losartan Potassium and Hyrdochlorothiazide, Tablets, 50 mg/12.5 mg, 90 Tablets
Losartan Potassium and Hydrochlorthiazide Tablets, 100 mg/12.5 mg, 90 Tablets
Losartan Potassium and Hydrochlorthiazide Tablets, 100 mg/25 mg, 90 Tablets
Losartan Potassium Tablets, 50 mg, 30 Count Bottle
Losartan Potassium Tablets, 50 mg, 90 Count Bottle
Losartan Potassium Tablets, 50 mg, 1000 Count Bottle
Losartan Potassium Tablets, 100 mg, 90 Count Bottle
Losartan Potassium Tablets, 50 mg, 100 Count Unit Dose Cartons
Testosterone Cypionate 100 mg/ml Sesame Oil, Injectable, 12ml Vial
Testosterone Cypionate 150 mg/ml Sesame Oil, Injectable, 12 ml Vial
Testosterone Cypionate 200 mg/ml Sesame Oil, Injectable, 9 ml Vials, 12 ml Vials
Testosterone Cypionate 200 mg/ml Ethyl Oleate, Injectable, 7.2 ml Vial, 9.6 ml Vial, 10.8ml Vial
Testosterone Cypionate 100 mg/ml, Oil Injectable, 12 ml Vial
Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/ml, Injectable, 3ml Vial
Hydroxyprogesterone Caproate 250 mg/ml Sesame Oil, Injectable, 5 ml Vial
Prostaglandin 20 mcg/ml/Procaine 0.1%, Injectable, 2.5ml Vial, 10 ml Vial
Hydroxocobalamin 10 mg/ml, Injectable, 30 ml Vial
ActivEyes Nighttime Lub Eye, Ointment, 3.5 gm
Altaire Altacaine, Solution, 15 ml
ActivEyes Altachlore, Ointment, 3.5 gm
ActivEyes Altachlore, Solution, 15 ml
ActivEyes Altalube, Ointment, 3.5 gm
Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, 2.5 ml
Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, 5ml
Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%, 10ml
Altaire Diclofenac Sodium Solution 1%, 5ml
Altaire Fluorescein Sodium with Proparacaine HCl, Ophthalmic Solution, 5ml
Altaire Eye Wash, 15ml
Altaire Eye Wash, 15ml
Altaire Eye Wash, 4 Fl. Oz.
Altaire Goniotaire, 15 ml
Altaire Homatropaire, 5 ml
NanoTears HA PF Multi Dose Lubricant Gel Drops, 10 ml
Nano Tears MO Clear Emollient Mineral Oil Lipids, 10 ml
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 ml
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin, 2x10ml
Nano Tears TF Clear Emollient Tear Film Replenishment Essential Lipids Preservative Free Multi-Dose, 7.5ml
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free, 0.6ml x32 ct
Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, 0.6ml x32 ct.
Nano Tears TF Clear Emollient Lubricant Gel Drops, 2x15 ml
Nano Tears TF Clear Emollient Lubricant Gel Drops, 15ml
Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, 2x10ml
Nano Tears XP Clear Emollient Lubricant Gel Drops, 10ml
Altaire Ofloxacin 0.3% Ophthalmic Solution, 5ml
ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF, 7.5ml
ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF, 7.5ml
ActivEyes Lubricant Eye Ointment Preservative Free, 3.5 gm
Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL
Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL
Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL
Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, 15 mL
Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL
Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL
TRP/ TARGET up & up intensive relief lubricating eye drop, 10 mL
TRP Blur Relief, 15 mL
TRP Pink Eye Relief, 4 g
Ocusoft Homatropine Hydrobromide Ophthalmic Solution 5%, 5 mL
Ocusoft Tetcaine Hydrochloride Ophthalmic Solution USP, 0. 5%, 15 mL
Ocusoft Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, 15 mL
Ocusoft Tetravisc Forte, 0.6 mL x 12 pcs
Ocusoft Tetravisc Forte, 5 mL
Ocusoft Tetravisc, 0.6 mL x 12 pcs
Ocusoft Tetravisc, 5 mL
Ocusoft Flucaine, 5 mL
Ocusoft Eye Wash, 1fl oz
Ocusoft Eye Wash, 4 fl oz
Ocusoft Tears Again Lubricant Eye Drops, 15 mL
Ocusoft Tears Again Lubricant Eye Drops, 30mL
Ocusoft Tears Again Lubricant Eye Ointment Nighttime Relief, 3.5g
Ocusoft retaine NaCl Ophthalmic Ointment, 3.5g
Ocusoft retaine NaCl Ophthalmic Solution, 15mL
Accutome Accu-WASH, 4 FL. OZ.
FreshKote Lubricant Eye Drops, 15 mL
Grandall Colirio Ojo De Aguila Eye Drops, 15 mL
Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, 15mL
Grandall Oftal-Mycin Ophthalmic Ointment, 3.5 g
Clear Eyes Redness Relief, 15 mL
Clear Eyes Redness Relief, 30 mL
Clear Eyes Redness Relief (Handy Pocket Pal) 0.2 FL. Oz.
Clear Eyes Redness Relief (Little Drug) 0.2 FL. Oz.
Clear Eyes Redness Relief (Select Corp) 0.2 FL. Oz.
Methylcobalamin 1 mg/ml, Injectable, 8 ml Vial
Methylcobalamin 10 mg/ml, Injectable, 5.4 ml Vial
Pap/Phen/Pge1 22 mg/0.8mg/8mcg/ml, Injectable, 5ml Vial
Pap/Phen/Pge1 30 mg/2mg/20mcg/ml, Injectable, 10ml Vial
Pap/Phen/Pge1 30 mg/0.83mg/10mcg/ml, Injectable, 5 ml
Pap/Phen/Pge1 18 Mg/0.6mg/5.88mcg/ml, Injectable, 5 ml Vial
Chorionic Gonadotropin 2,000u/ml PF, Injectable, 8 ml Vial
Glutathione 100 mg/ml, Inhalation Solution, 45 ml Vial
Serum Tears 20% Eye Drops PF Solution, 15 Ea, 15 ml Vials, 12 Ea
Anastrozole Tablets 1 mg, 30-Count Bottles, 1000-Count Bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/10/2019
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free 7.5 mL
Neo-Polycin HC (Neomycin and Polymixin B and Bacitracin Zinc and Hydrocortisone Acetate) 3.5 gm
Bacitracin Ophthalmic Ointment 3.5 gm
Equate Comfort Gel Lubricant Eye Gel Twin Pack 2 x 15 mL
Equate Eye Allergy Relief Drops 15 mL
Equate Night & Day Restore Tears Lubricant Eye Pack 3.5g and 15mL
Equate Restore PM Nighttime Lubricant Eye Ointment 3.5 gram
Equate Restore Tears Lubricant Eye Drops Twin Pack 2 x 15 mL
Equate Sterile Lubricant Stye Ointment 3.5 gram
Equate Support Advanced Lubricating Eye Drops Dose Preservative Free 25 count (0.6 mL fill)
Equate Support Advanced Twin Pack 2 x 15 mL
Equate Support Moisture Lubricant Eye Drops 10 mL
Lubricant Eye Drops Moisturizing Twin Pack 2 x 15 mL
Lubricant Eye Drops Moisturizing 15 mL
Lubricant Eye Ointment PF Soothing 3.5 gram
Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment 3.5 gm
Neo-Poly Dex (Neomycin and Polymixin B and Dexamethasone) 3.5 gm
Polycin (Polymixin B and Bacitracin Zinc) 3.5 gm
Puralube Ophthalmic Ointment 1 gm
Puralube Ophthalmic Ointment 3.5 gm
Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment 3.5 gram
Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops 15 mL
Sulfacetamide Sodium Ophthalmic Ointment 3.5 gm
Support Harmony Lubricant Eye Drops 10 mL
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
07/03/2019
Fluorouracil Injection, 5g/100mL (50mg/mL), 100 mL vial
Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card)
Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10)
Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card)
Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card)
Atropine Sulfate Preservative-Free Injection, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe
Brilliant Blue Ophthalmic Preservative-Free Injection, 0.5mg/mL (0.05%), 1 mL SDV
Chlorpromazine HCL Injection, *Contains Sulfites*, 25mg/mL, 1mL in a 5mL Sterile SDV
Dexamethasone Sodium Phosphate Preservative-Free Sterile Solution for Injection, 24mg/mL, 1mL
Sterile Single-Use Syringe
Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe
Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag
Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag
Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag
Lidocaine 0.5%/Phenylephrine 0.75% Preservative-Free Injection, n/a, 1mL Sterile SDV
Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV
Naloxone HCL Preserved Injection, 500mg/50mL (10mg/mL), 50mL Sterile MDV
Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe
Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use
Syringe
Phenylephrine HCL Preservative-Free Injection in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, n/a, 10mL Single-Dose Syringe
Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle
Sodium Bicarbonate Injection, 8.4% 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV
Succinylcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe
Succinylcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe
Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/26/2019
Anastrozole Tablets, 1mg, 30-count unit dose blisters per carton
Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablet, 30-count box
Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablet, 20-count box
Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, 30-count box
Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, 20-count box
Robafen DM, Dextromethorphan HBr, USP 10mg, /Guaifenesin, USP 100mg, 118mL (4oz) bottle
Cetirizine HCL Oral Solution 1 mg/ml, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 5mg/5mL, 4 FL. oz. Bottle
Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle
Cetirizine Oral Solution 1 mg/ml, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/19/2019
Risperidone Oral Solution, 1 mg/ml, 30 ml Bottle
Children's Acetaminophen Liquid, Cherry Flavor, 160 mg Per 5 ml, 4 FL. Oz. (118 ml) Bottle
Allergy Liquid Antihistamine, Diphenhydramine HCl USP, Alcohol Free, 12.5 mg/5 ml, 4 FL. Oz. (118 ml) Bottle
Children's MAPAP Acetaminophen Liquid, Cherry Flavored, 160 mg Per 5 ml, 4 FL. Oz. (118 ml) Bottle, One Pint (473 ml) Bottle
Robafen Cough Formula Expectorant Guaifenesin USP 200 mg in Each 10 ml, 4 Fl. Oz. (118 ml) Bottle, One Pint (473 ml) Bottle
Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg Per 5 ml, One Pint (473 ml) Bottle
Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 ml And Guaifenesin, USP 200 mg/10 ml), 4 oz. Bottle, 8 Oz. Bottle, 16 Oz. Bottle
Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each Teaspoonful Contains Diphenhydramine Hydrochloride, USP 12.5 mg, 4 Fl. Oz. (118 ml) Bottle, One Pint (473 ml) Bottle
Pseudoephedrine Oral Solution, 30 Mg in Each Teaspoonful, Nasal Decongestant, One Pint (473 ml) Bottle
Nasal Decongestant Spray Regular, Oxymetazoline HCl, 0.05%, 0.5 FL. Oz. (15 ml) Bottle 1 FL. Oz. (30 ml) Bottle
Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg In Each 2 teaspoonfuls (10ml)), 4 Fl. Oz. (118 ml) Bottle
Pedia Relief Cough-Cold Oral Solution, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg; Dextromethorphan HBr, USP 10 mg; Pseudoephedrine HCl, USP 30 mg In Each 2 Tsp (10 ml)), 4 Fl. Oz. (118 ml) Bottle
Biscolax Laxative (Bisacodyl, USP 10 mg), 12 Suppositories Per Carton, 100 Suppositories Per Carton
Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5ml, 473 ml (16 FL. Oz.) Bottle
Hyoscyamine Oral Drops, 0.125 mg/ml, 15 ml Bottle (0.5 FL. Oz.)
Hyoscyamine Sulfate Elixir, 0.125 mg Per 5 ml, 473 ml (16 Oz.) Bottle
Cetirizine HCL Oral Solution, 1mg/ml, 4 Oz - BULK
Acetic Acid Otic Solution, 2%, 15 ml Bottle
Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg Per 5 ml, One Pint (473 ml) Bottle
Guaifenesin DAC Oral Solution, Sugar Free, (Guaifenesin, Pseudoephedrine HCl And Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg Per 5 ml, One Pint (473 ml) Bottle
Phenobarbital Oral Solution, USP, 20 mg Per 5 ml, One Pint (473 ml) Bottle
Pain & Fever Oral Solution (Acetaminophen 160 mg/5 ml), Sugar Free, Aspirin & Alcohol Free, Cherry Flavored, 4 Fl. Oz. Bottle, One Pint (473 ml) Bottle
Kid Kare Childrens Cough/Cold Liquid, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg In Each 2 Tsp (10ml)), 4 Fl. Oz. Bottle
Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 ml, Alcohol Free Non-Narcotic Expectorant, One Pint (473 ml) Oz. Bottle
Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg Per 5 ml, 4 FL. Oz. (118 ml) Bottle, One Pint (473 ml) Bottle
Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 ml, 4 FL. Oz. (118 ml) Bottle, One Pint (473 ml) Bottle
Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. Oz. (118 ml) Bottle
Lactulose Solution, 10 G/15 ml, 16 FL. Oz., 32 FL. Oz.
Lactulose Solution, 10 G/15 ml, 16 FL. Oz. Bottle
Memantine Hydrochloride Oral Solution, 2 mg/ml, 12 Oz. Bottle
Memantine Hydrochloride Oral Solution, 2 mg/ml, 13 Oz. Bottle
Hydrocortisone Acetate Suppositories, 25 mg, 12 Adult Suppositories Per Carton, 24 Adult Suppositories Per Carton
Laxative Suppositories (Bisacodyl USP, 10 mg), 12 Suppositories Per Carton, 100 Suppositories Per Carton
Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories Per Carton
Anu-Med Brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Suppositories Per Carton
Cetirizine Hydrochloride Oral Solution, 1 mg/ml, 120 ml Bottle
Cetirizine Hydrochloride Oral Solution, 1mg/ml, 120 ml Bottle
Risperidone Oral Solution, 1 mg/ml, 30 ml Bottle
Hydrocodone Bitartrate And Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg Per 5 ml, 16 FL. Oz. (473 ml) Bottle
Hydrocodone Bitartrate And Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg Per 5 ml, 16 FL. Oz. (473 ml) Bottle
Bisacodyl Suppositories
Bacteriostatic Water for Injection, 10 ml Vials
B-Complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 Mg, Pyridoxine 2mg, Depanthenol 5mg), 10 ml Vials
Human Chorionic Gonadotropin, 10,000 IU, Vials
Human Chorionic Gonadotropin, 5,000 IU, Vials
Human Chorionic Gonadotropin, 12,000 IU, Vials
Ipamorelin Acetate, 9 mg/9ml , Injectable Vials
Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 Mg), 10 ml Injectable Vials
Nandrolone Decanoate, 200 mg/ml, 10 ml Vials
Sermorelin/Ipamorelin, 18 mg/15 mg, 10 ml Vials
Sermorelin/GHRP, 2 9 mg/9 mg, Vials
Sermorelin/GHRP, 2 9 mg/6 mg, Vials
Sermorelin/GHRP, 2 & 6 (3-3-3 mg), Vials
Sermorelin/GHRP, 2 &6 (9-9-9-mg), Vials
Sermorelin/GHRP, 2 &6 (9-9-9 mg), Vials
Testosterone, 200 mg/ml, 30 ml Vials
Testosterone Cyp/Pro, 95/5%, 10 ml Vials
Testosterone Cypionate, 200 Mg/ml, 5 ml Vials, 10 ml Vials
Trimix 30mg/1 mg/10mcg/ml (30 mg Papaverine, 1mg Phentolamine Mesylate, 30 mcg Alprostadil), 5 ml Vials
ZYFLO CR (Zileuton) Extended-Release Tablets, 600 mg, 120-Count Bottles
Zileuton Extended-Release Tablets, 600 mg, 120-Count Bottles
Estradiol Vaginal Inserts, 10 mcg, Packaged in Box Of 8 Vaginal Inserts (With Disposable Applicators)
Heparin Sodium 25,000 USP Units Per 250 ml (100 USP Units Per ml) In 5% Dextrose Injection, 250 ml EXCEL Container Bag
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/12/2019
Losartan Potassium, 50 mg, 30, 90, 1000-count bottles, Tablets
Losartan Potassium, 100 mg, 90-count bottles, Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
06/04/2019
Bevacizumab, 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Injection
Cefdinir for Oral Suspension, 250mg/5mL, 60 mL bottle, Powder for oral suspension
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/29/2019
Articaine Dental, Articane hydrochloride 4% and epinephrine 1:100,000, n/a, 50 cartridges. 1.7 mL each, Tablets
Losartan Potassium, 25 mg, 90-count bottles, Film Coated Tablets
Losartan Potassium, 50 mg, 90, 1000-count bottles, Film Coated Tablets
Losartan Potassium, 100 mg, 90, 1000-count bottles, Film Coated Tablets
Losartan Potassium, 25 mg, 30, 90, 1000-count bottles, Tablets
Losartan Potassium, 100 mg, 90, 1000-count bottles, Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/22/2019
Losartan Potassium Tablets, 50 mg, 30, 90-count bottles
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/15/2019
Promacta oral suspension, 12.5 mg, Bottle
Fentanyl Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton
Acyclovir Tablets, 400 mg, 100 count bottles
Carvedilol Tablets, 6.25 mg, 500 count bottles
Mycophenolate Mofetil for Injection, 500 mg, 4 Single Dose Vials
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/08/2019
Mycophenolate Mofetil, 500 mg, 1 Vial Injection
Losartan Potassium, 25 mg, 90-count bottle, Tablets
Losartan Potassium, 50 mg, 90, 1000-count bottle, Tablets
Losartan Potassium, 100 mg, 90, 1000-count bottle, Tablets
BPlex (methylcobalamin 1000 mcg/ml pyridoxal 5 phosphate 20mg/ml dexpanthenol 250mg/ml), 10 ml multidose vial, Compounded Injectable
BPlex (methylcobalamin 1000 mcg/ml pyridoxal 5 phosphate 20mg/ml dexpanthenol 250mg/ml) , 10 ml multidose vial, Compounded Injectable
Glutathione, 200mg/ml, 10 ml and 12 ml multidose vial, Compounded Injectable
HCG (chorionic gonadotropin 1000 IU/ml pep 25 mg/ml), 5 mL multidose vial, compounded injectable
Lipoplex (methionine 25 mg/ml inositol 50 mg/ml choline chloride 50 mg/ml hydroxocobalamin 500 mc/ml dexpanthenol 50 mg/ml pyridoxine HCl 50 mg/ml), 10 ml multidose vial, Compounded Injectable
Test D (testosterone cypionate 200mg/ml Vitamin D3 5,000IU/ml), 5 ml multidose vial, Compounded Injectable
Test D (testosterone cypionate 200mg/ml Vitamin D3 5,000IU/ml), 5 ml multidose vial, Compounded Injectable
Test PROCYP (testosterone cypionate 200mg/ml testosterone propionate 20mg/ml), 5 ml multidose vial, Compounded Injectable
Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial, Compounded Injectable
TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose, Compounded Injectable
Losartan Potassium, 25 mg, 90, 1000 count bottle, Tablets
Losartan Potassium, 50 mg, 90, 1000 count bottle, Tablets
Losartan Potassium, 100 mg, 90, 1000 count bottle, Tablets
Losartan Potassium and Hydrochlorothiazide, 50mg/12.5mg, 30, 90, 1000 count bottle, Tablets
Losartan Potassium and Hydrochlorothiazide, 100mg/12.5mg, 90, 1000 count bottle, Tablets
Losartan Potassium and Hydrochlorothiazide, 100mg/25mg, 30, 90, 1000 count bottle, Tablets
Bevacizumab, 1.25 mg/0.05 mL 31G MJ Syringe, Intravitreal Injection
Losartan Potassium, 50 mg, 50 tablets (5x10) Unit Dose, Tablets
Losartan Potassium, 25 mg, 50 tablets (5x10) Unit Dose, Tablets
Losartan Potassium, 50 mg, 30 tablet bottles, Tablets
Hydromorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag. Compounded Injectable
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
05/01/2019
Dexmedetomidine, 400 mcg in NS 100 mL, bag
Clindamycin, 900 mg in NS 50 mL, bag, Mixed bag
Diltiazem, 250 mg in NS 250 mL, bag, Mixed bag
Labetalol, 20 mg/4 mL, 20 mg in 4 mL syringe, Syringe
Magnesium Sulfate, 1 GM in NS 50 mL, bag, Mixed bag
Magnesium Sulfate, 2 GM in NS 50 mL, bag, Mixed bag
Magnesium Sulfate, 4 GM in NS 50 mL, bag, Mixed bag
Magnesium Sulfate, 6 GM in NS 50 mL, bag, Mixed bag
NICARdipine, 25 mg in NS 250 mL, EXCEL bag, Mixed bag
Norepinephrine, 16 mg in NS 250 mL, bag, Mixed bag
Oxytocin, 30 units in NS 500 mL, bag, Mixed bag
Alteplase, 1 mg/mL 1 mL, 10 mL syringe, Syringe
Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, Syringe
Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, Syringe
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, Syringe
CeFAZolin, 1 GM in NS 100 mL bag, 100 mg/mL (10 mL) syringe, Syringe
CeFAZolin 2 GM in NS 100 mL bag, 100 mg/mL (20 mL) syringe, Syringe
CeFAZolin, 3 gm, 100 mg/mL 30 mL syringe, Syringe
CefTRIAXone, 1 GM, 100 mg/mL 10 mL syringe, Syringe
Chlorothiazide, 100 mg, 3.57 mL syringe, Syringe
Heparin Pork, 30,000 Units in NS 1000 mL, bag, Mixed bag
Phenylephrine, 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Syringe
Phenylephrine, 20 mg NS 250 mL, bag, Mixed bag
Phenylephrine, 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL
Sodium Bicarbonate, 150 mEq in D5W 1000 mL, bags, Mixed bag
Sodium Citrate 4% Flush Syringe, 40 mg/mL, 3 mL syringe, Syringe
Vancomycin, 1000 mg in NS 250 mL, bag, Mixed bag
Vancomycin, 1250 mg in NS 250 mL, bag, Mixed bag
Vancomycin, 1500 mg in NS 250 mL, bag, Mixed bag
Vancomycin, 1750 mg in 0.9% Sodium Chloride 500 mL, bag, Mixed bag
Vancomycin, 2000 mg in 0.9% Sodium Chloride 500 mL, bag, Mixed bag
DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use
Losartan Potassium Tablets, 25 mg, 30. 90, 1000 count bottle, Tablets
Losartan Potassium Tablets, 100 mg, 90, 1000 count bottle, Tablets
Bevacizumab 31G Injectable, 1.25mg/0.05mL Injectable
Ketorolac Tromethamine Injection, 60 mg/2 ml, 2 ml, Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/24/2019
MSM, Eye Drops, 15%, 30ml, Eye Drops
Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, n/a, 15ml, Eye Drops
Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, n/a, 15ml, Eye Drops
Dr. Berne's MSM DROPS, 15%, 30ml, Solution
Testosterone Cypionate Injection, 2000 mg/10 mL (200 mg/mL), 10 mL Vial, intramuscular
Testosterone Cypionate Injection, 200 mg/mL, 1 mL Vial, intramuscular
Testosterone Cypionate Injection, 1000 mg/10 mL (100 mg/mL), 10 mL Vial, intramuscular
Acetylcysteine Ophthalmic Eye Drop, 10%, 2 mL droptainer, Compounded eye drops
Atropine Eye Drops, 0.01%, 1 mL and 2 mL Dropper, Compounded eye drops
Amphotericin B Eye Drops, 0.15%, 2 mL Droppers, Compounded eye drops
Vancomycin Inhalation, 125 mg/3mL, 3 mL Vial, Compounded Inhalation
Dexamethasone Injection, 24 mg/mL, 10 mL Vial, Compounded Injectable
DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Compounded Injectable
Estradiol Cypionate, 10 mg/mL, 5 mL Vial, Compounded Injectable
Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, , 30 mL Syringe, Compounded Irrigation
Gentamicin L Irrigation, 250 mg/1000 m, 1000 mL, Compounded Irrigation
HCG Injection, 1,000 U/mL, 30 mL, Compounded Injectable
HCG, 11,000 Units, , Compounded Injectable
HCG 20 Day Injection, 2625 Units/4 mL, Compounded Injectable
HCG 23 Day, 2876 Units/4.6 mL Vial, Compounded Injectable
HCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Compounded Injectable
HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Compounded Injectable
HCG, 20,000 units/vial, Compounded Injectable
HCG 23 Day Injection Extra Strength, vials, Compounded Injectable
HCG, 4,100 Units/vial Injection, Compounded Injectable
HCG 40 Day Injection Extra Strength, vials, Compounded Injectable
Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 mL Syringe, Compounded Injectable
Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 mL Syringe, Compounded Injectable
Heparin 10,000 U/Bupivacaine 0.5% 10 mL, Sodium Bicarbonate 8.4% 50 mL, 61 mL Syringe, Compounded Injectable
Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Compounded Injectable
Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, , , Compounded Injectable
Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine 10 mg, benzyl alcohol/ water, , , Compounded Injectable
Methylcobalamin , 1 mg/mL Injection, 2 mL Vial, Compounded Injectable
Methylprednisolone PF Ophthalmic, 1%, 3 mL Droppers, Compounded eye drops
Morphine Sulfate Inhalation, 5 mg/3mL, 3 mL Vials, Compounded Inhalation
Penicillin G, 100,000/mL, 10 mL Syringe, Compounded Injectable
Phenylephrine Injection, 1 mg/mL, 10 mL Vial, Compounded Injectable
Polyhexamethylene Biguanide Ophthalmic Drops, 0.02%, 2 mL Dropper, Compounded eye drops
Prostaglandin, 20 mcg/mL, 10 mL Vial, Compounded Injectable
Prostaglandin, 40 mcg/mL, Vial, Compounded Injectable
Prostaglandin, 60 mcg/mL, Vial, Compounded Injectable
Prostaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Compounded Injectable
Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Compounded Injectable
Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Compounded Injectable
Prostaglandin Tri-Mix 50:30:1, 10 mL Vial, Compounded Injectable
Sermorelin, 0.3 mg/0.5 mL, 10 mL Vial, Compounded Injectable
Sermorelin, 0.4 mg/0.5 mL, 10 mL Vial, Compounded Injectable
Serum Tears 20% Drops, 1 mL Droptainer, Compounded drops
Serum Tears 30% Drops, 1 mL Droptainer, Compounded drops
Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Compounded Injectable
Bacitracin 3000U/30 mL Irrigation,30 mL Syringe, Compounded Irrigation
Testosterone Cypionate 250 mg/mL Sterile Injection, 5 mL Vial, Compounded Injectable
Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Compounded Injectable
Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Compounded Injectable
Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Compounded eye drops
Interferon 1 Million IU/mL Eye Drops, 1 mL Droptainer, Compounded eye drops
Prostaglandin Tri-Mix 60:30:1 Injection, 2 mL Vial, Compounded Injectable
Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution,1000 mL bottle, Compounded Solution
Lidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Compounded Injectable
EDTA Sterile Injection (Preservative Free), 1%, Compounded Injectable
Sodium Bicarbonate Injection, 8.40%, 10 mL Vial, Compounded Injectable
Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Compounded Injectable
Gentamicin Sterile Water for Irrigation, 160 mg/1000 mL, 1000 mL Bottle, Compounded Irrigation
Gentamicin Sterile Water for Irrigation, 240 mg/500 mL, 60 mL Syringe, Compounded Irrigation
Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Compounded Injectable
Estrone Oil Injection, 5mg/mL, 10 mL Vial, Compounded Injectable
HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Compounded Injectable
Papaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Compounded Injectable
Papaverine 30 mg/mL Injection, 10 mL Vial, Compounded Injectable
Phenol 10% Injection, 5 mL Vial, Compounded Injectable
Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Compounded Injectable
Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Compounded Injectable
Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection, 2 mL Vial, Compounded Injectable
Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Compounded Injectable
Prostaglandin Tri-Mix 30:30:1 Injection, 2 mL Vial, Compounded Injectable
Divalproex Sodium Extended-Release Tablets, 100, 500-count bottle, Tablets
Fentanyl Transdermal System, 12 mcg/h, 5 systems, transdermal patches
Losartan potassium tablets, 25mg, 50 mg, 100 mg, 30, 90, 1000-count bottle, Tablets
Losartan potassium and Hydrochlorothiazide tablets, 50mg/12.5mg, 100mg/12.5 mg, 100mg/25 mg, 30, 90, 1000-count bottle, Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/17/2019
SODIUM CHLORIDE PRES-FREE OPHTHALMIC STERILE SOLUTION, 5%, 20ml, Compounded eye drops
DEXAMETHASONE (NAPO4) OPHTHALMIC PRES-FREE SOLUTION, 0.10%, 10ml, Compounded eye drops
ACETYL-L-CYSTEINE P.F. OPHTHALMIC SOLUTION, 10%, 10ml, Compounded eye drops
HYDROXYPROGESTERONE CAPROATE OIL, 250 MG/ML, 10ml, 9ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1 INJECTABLE, 22-0.8 MG-8 MCG/ML, 5ml, 10ml, 6ml, Compounded Injectable Drug
PGE1 INJECTABLE, 40 MCG/ML, 5ml, 10ml, 6ml, 9ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE, penile injection, 30-1 MG/ML, 10ml, 9ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 30-1 MG-10 MCG/ML, 5ml, 6ml, 9ml, 10ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 12-1MG-10MCG/ML, 10ml, 9ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 17.16-0.57MG-19.45MCG/ML, 5ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 23-0.96MG-19.2MCG/ML, 5ml, 6.5ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 30-1.6 MG-16 MCG/ML, n/a, Compounded Injectable Drug
PGE1-LIDOCAINE, 40 MCG-1% /ML, 10 ml, 9ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE, 15-0.5MGMG/ML, 9ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE, 30-0.5 MG/ML, 9ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 30-2 MG-30 MCG/ML, 5ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 15-0.5MG-10MCG/ML, 9ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 16.6-0.55 MG-11.1 MCG/ML, 10 ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 17.64-0.58MG-5.88MCG/ML, 9 ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 22.5-0.8MG-8.3MCG/ML, 5 ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 9-1 MG-10 MCG/ML, 18 ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 30-1 MG-20 MCG/ML, 5 ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 15-0.25MG-6MCG/ML, 5 ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 17.44-0.58MG-5.8MCG/ML, 5 ml, Compounded Injectable Drug
PAPAVERINE-PHENTOLAMINE-PGE1, 17.44-0.64MG-5.8MCG/ML, 5 ml, Compounded Injectable Drug
Gavilyte-N, Sodium chloride, Sodium Bicarbonate and Potassium Chloride Oral Solution, PEG-3350, Solution
Pravastatin Sodium Tablets, 20 mg, 500 count bottle, Tablets
Losartan, 50mg, 30 count each blister card, Tablets
Bismuth Subsalicylate Oral Suspension, OTC, 262mg/15mL, unit dose cups, Suspension
Phenobarbital Oral Solution, 20 mg/5mL, unit dose cup, Solution
Losartan Potassium, 100 mg, 30 count bottles, Tablets
LOSARTAN POTASSIUM, 25 mg, 90, 1000 count bottles, Tablets
LOSARTAN POTASSIUM, 50 mg, 30, 90, 1000 count bottles, Tablets
LOSARTAN POTASSIUM, 100 mg, 90, 1000 count bottles, Tablets
Losartan Potassium / Hydrochlorothiazide, 50mg/12.5mg, 30, 90, 1000 count bottles, Tablets
Losartan Potassium / Hydrochlorothiazide, 100mg/12.5mg, 30, 90 count bottles, Tablets
Losartan Potassium / Hydrochlorothiazide, 100mg/25mg, 30, 90, 1000 count bottles, Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/10/2019
8.4% Sodium Bicarbonate Injection, 50mEq, 50ml single dose vial, Injection
Morphine Sulfate
Cefuroxime, 10mg/ml, Single Dose Vial, Injection
Losartan Potassium, 50mg, 30 count bottle, Tablets
Pantoprazole Sodium Delayed-Release, 40mmg, 90 count bottle, Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
04/03/2019
Gel Hand Sanitizer, 70% , 37ml, 118ml, 540ml bottles, Hand Sanitizer
Advanced Gel Hand Sanitizer, 62%, 37ml & 540ml bottles, Hand Sanitizer
Moisturizing Gel Hand Sanitizer, 62%, 118ml bottle, Hand Sanitizer
Quick-Care Foam Hand Sanitizer, 62%, 1.5 fl oz, Hand Sanitizer
Express Gel Hand Sanitizer, 70%, 1.25 fl oz, Hand Sanitizer
Fayosim (levonorgestrel and ethinyl estradiol) tablets, 0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg, Cartons Tablets
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution), 0.2%/0.5%, 5ml bottles, Opthalmic Solution
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/27/2019
Docusate Sodium, 100mg, 10 x 10 unit dose blister cards, Tablets
Alprazolam Tablets, 0.25mg, 10x10 per carton, Tablets
Valsartan Tablets, 320mg, 90 count bottle, Tablets
Amlodipine and Valsartan Tablets, 10mg/160mg, 30 count bottle, Tablets
Valsartan Tablets, 40mg, 30 count bottle, Tablets
Valsartan Tablets, 80mg, 90 count bottle, Tablets
Valsartan Tablets, 160mg, 90 count bottle, Tablets
Losartan Potassium and Hydrochlorothiazide Tablets, 100mg/25mg, 90 count bottle, Tablets
Losartan Potassium Tablets, 25mg, 90, 500, 1000 count bottles, Tablets
Losartan Potassium Tablets, 50mg, 90, 500, 1000 count bottles, Tablets
Losartan Potassium Tablets, 100mg, 30, 90, 1000 count bottles, Tablets
Losartan Potassium Tablets, 50mg, 50 Tablets (5x10) Unit Dose boxes, Tablets
Losartan Potassium and Hydrochlorothiazide Tablets, 50mg/12.5mg, 50 Tablets (5x10) Unit Dose boxes, Tablets
Losartan Potassium and Hydrochlorothiazide Tablet, 100 mg/12.5 mg, 50 Tablets (5x10) Unit Dose boxes, Tablets
Valsartan Tablets, 160mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Tablets
Losartan Potassium Tablets, 25mg, 30 count bottle, Tablets
Losartan Potassium Tablets, 50mg, 30 count bottle, Tablets
Losartan Potassium Tablets, 100mg, 30 count bottle, Tablets
Losartan Potassium Tablets, 50mg, 30, 90 count bottle, Tablets
Valsartan Tablets, 40mg, 30 count bottle, Tablets
Valsartan Tablets, 80mg, 90 count bottle, Tablets
Valsartan Tablets, 160mg, 90 count bottle, Tablets
Valsartan Tablets, 320mg, 90 count bottle, Tablets
Hydrocortisone and Acetic Acid Otic Solution, 10ml, Dropper, Otic Solution
Volumex (Iodinated I 131 Albumin) Injection, 25uCi, Syringe, Injection
Hydromorphone HCl, 1mg/5ml, 0.9% Sodium Chloride, Injectable Solution
Fentanyl Injectable Solution, 1000 mcg/100 mL, 0.9% Sodium Chloride, Injectable Solution
Fentanyl Injectable Solution, 2500 mcg/250 mL, 0.9% Sodium Chloride, Injectable Solution
Midazolam Benzodiazepine, 50 mg/50 mL, 0.9% Sodium Chloride, Injectable Solution
Phenylephrine HC, 500mcg, 0.9% Sodium Chloride, Injectable Solution
Glycopyrrolate Injectable Solution, 1 mg/5 mL, Single Use Syringe, Injectable Solution
Phenylephrine HCl, 400mcg 0.9% Sodium Chloride, Injectable Solution
Phenylephrine HCl, 1mg/5ml, 0.9% Sodium Chloride, Injectable Solution
Neostigmine Methylsulfate Injection Solution, 5 mg/5mL, Single Use Syringe, Injectable Solution
Glycopyrrolate 0.6 mg/3 mL, Single Use Syringe, Injectable Solution
2% Lidocaine HCl, 60 mg/3 mL, Single Use Syringe, Injectable Solution
2% Lidocaine HCl, 100mg/5ml, Single Use Syringe, Injectable Solution
Phenylephrine HCl, 800mcg, 0.9% Sodium Chloride, Injectable Solution
Esmolol HCl, 100 mg/10 mL, Single Use Syringe, Injectable Solution
Heparin,10 Units/10 mL, 0.9% Sodium Chloride, Injectable Solution
Heparin, 5,000 Units/5mL, 0.9% Sodium Chloride, Injectable Solution
Phenylephrine HCl, 1mg, Sterile Water, Injectable Solution
Morphine Sulfate, 30 mg/30 mL, 0.9% Sodium Chloride, Injectable Solution
Phenylephrine HCl, 1,200 mcg, 0.9% Sodium Chloride, Injectable Solution
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/20/2019
Telmisartan & Hydrochlorothiazide, 40mg/12.5mg, 80mg/12.5mg, 80mg/25mg, 30-count bottles, Tablets
Gentamicin Sulfate Opthalmic Solution, 0.3%, 5ml bottles, Opthalmic Solution
Oxygen, Refrigerated Liquid
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
03/06/2019
Moxifloxicin, 0.50%, 3ml bottle, Opthalmic Solution
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/27/2019
LOSARTAN POTASSIUM 100mg, 30, 90, 1000 count bottles, Tablets
LOSARTAN POTASSIUM 50mg, 30, 90, 1000 count bottles, Tablets
LOSARTAN POTASSIUM 25mg, 90 count bottle, Tablets
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE, 100 mg/12.5 mg, 90, 1000 count bottle, Tablets
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE, 50 mg/12.5 mg, 90, 1000 count bottle, Tablets
Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Injection
0.9% Sodium Chloride Injection 0.90%, 1000ml, Injection
Divalproex Sodium Extended-release, 250mg, 100 count bottle, tablets
Tubby Todd Bath Co, 100% NATURAL DREAM CREAM, 3.5fl oz, Cream
Fentanyl in 0.9% Sodium Chloride QS, 5 mcg/0.5 mL, 0.1ml, Sterile single use syringe
Moisturizing Lubricant Eye Drops, 0.25%, 0.5fl oz, eye Drops
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/20/2019
Levetiracetam in 0.54 % Sodium Chloride Injection, 15mg/ml, 0.54% Sodium Chloride Injection, IV Infusion
CIDOFOVIR DIHYDRATE 10g
Acetylcysteine Ophthalmic Solution, 100mg/ml, Opthalmic Solution
Prednisolone and Moxifloxacin Ophthalmic Solution, 1%/0.5%, Combo Drops 3ml, Opthalmic Solution
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, Combo Drops 3ml, Opthalmic Solution
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution, 1%/0.5%/0.5%, Combo Drops 3ml, Opthalmic Solution
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6ml, Opthalmic Solution
Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3ml, Opthalmic Solution
Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09%, Combo Drops 3ml, Opthalmic Solution
Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine, 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL, 10 mL vial, Compounding Solution
Multi Trace, Zinc/Copper/Manganese/Selenium, 5mg/1mg/0.5mg/60mcg/ml, 30 mL vial, Injection
Vitamin D3, 50,000iu/mL, 5ml vial, Injection
Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium, 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mcg/mL, 10 mL, Injection
Methylcobalamin lyophilized Injection, 50,000 mcg Injection
Methylcobalamin lyophilized, 10,000 mcg, Injection
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine, 75 mg/75 mg/75 mg/10 mg/mL, 10 mL, Injection
Glutathione Injection, 200 mg/mL, 10 mL, Injection
Ascorbic Acid, Compounded-Tapioca, 450 mg/mL, 50 mL, Injection
Thymosin Beta-4, 15 mg, Injection
Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg, Injection
Sermorelin, 9mg, Injection
Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg, Injection
Sermorelin/GHRP2/GHRP6, 6mg/3mg/3mg, Injection
Ipamorelin+Modified GRF, 1-29, 9 mg/5mg, Injection
Ipamorelin, 9mg, Injection
Ipamorelin+Sermorelin 15mg/15mg, Injection
Ipamorelin, 15mg, Injection
IGF-1 LR3, 620 mcg Injection
Epithalon, 15mg, Injection
Bremelanotide (PT 141) 20mg, Injection
BPC 157, 10mg, Injection
HCG, Human chorionic gonadotropin, 11,000 units, Injection
HCG, Human chorionic gonadotropin 5,000 units, injection, Injection
HCG, Human chorionic gonadotropin 2,000 units, Injection
Sermorelin, 15mg
IGF-1-LR3, 3 mg Injection
Melanotan II, 10mg Injection
ICB-Complex, 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Injection
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10ml, Injection
Nicotinamide Adenine Dinucleotide, 0.5mg, 10ml vial, Injection
Niacinamide injection, 100mg/mL, 5ml vial, Injection
Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 10ml, 10ml vial, Injection
Zinc Sulfateinjection, 5mg/mL, 10ml vial, Injection
Folic Acid, Injection, 10 mg/mL, 10ml vial, Injection
Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Injection
Procaine HCl, 2%, 10mL vial, Injection
Pyridoxine HCl, 100 mg/mL, 10mL vial, Injection
Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Injection
Lysine HCl, 100 mg/mL, 10mL vial, Injection
Dexpanthenol, 250mg/mL, 10mL vial, Injection
Glycyrrhizic Acid, 8mg/mL, 10mL vial, Injection
Zinc Sulfate, 10mg/mg, 10mL vial, Injection
Folic Acid, 5mg/ml, 10mL vial, Injection
Infants' Ibuprofen, 50mg/1.25ml, 15ml bottle, Oral Suspension
Infants' Ibuprofen, 50mg/1.25ml, 30ml bottle, Oral Suspension
LET Gel 4%, 4%/0.05%, 3ml bottle, Syringe
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/13/2019
Soothe & Cool Protect Moisture Guard Skin Protectant, 59%, 3.5oz tubes, Skin Protectant
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing, 1%, 2oz tubes, Cream
Medline Remedy Essential Barrier Skin Protectant Ointment, 59%, 2 & 6 oz tubes, Ointment
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg, 23g bottle, Nasal Spray
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
02/06/2019
Gentamicin Sulfate Ophthalmic Solution 3mg/ml 5ml dropper bottle, Ophthalmic Solution
Gentamicin Sulfate Ophthalmic Solution 3mg/ml 5ml dropper bottle, Ophthalmic Solution
Omeprazole 4 mg/mL Suspension, 4mg/ml, Suspension
Progesterone 10%, Cream
Testosterone 0.1%, Cream
Promethazine 50mg/ml, Gel
Progesterone, 10mg SR Capsules
Domperidone, 10mg, 100 count bottle, Capsules
Cephalexin, 250mg/5ml, Oral Suspension
Irbesartan Tablets, 300mg, 90 count bottle, Tablets
Irbesartan and Hydrochlorothiazide 150/12.5mg, 90 count bottle, Tablets
Irbesartan and Hydrochlorothiazide 300/12.5mg, 90 count bottle, Tablets
Irbesartan and Hydrochlorothiazide 300/12.5mg, 90 count bottle, Tablets
Irbesartan and Hydrochlorothiazide 150/12.5mg, 90 count bottle, Tablets
Fexofenadine HCl, 180MG, 30/500 count bottle, Tablets
BromSite (bromfenac ophthalmic solution), 0.08%, 5ml bottles, Ophthalmic Solution
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/30/2019
5K Premium Enhancement capsule 5000 mg, Blister Box, Capsules
curaplex Epi Safe Administration and Training Kits, #8600-01100
curaplex Epi Safe Kit, 8600-01101, 1ml
Curaplex Epi Safe Kit, 8600-01102
Curaplex Epi Kit NOT FOR IV USE, 1ml
Fluocinolone Acetonide Topical Solution 0.01%, 60ml bottle, Topical Solution
Ezetimibe and Simvastatin Tablets 10mg/80mg, 1000 count bottle, Tablets
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/23/2019
Curaplex Epi Safe Administration and Training Kits
Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40mg/25mg, 30 & 90 count bottle, Tablets
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, 100 count bottle, Tablets
EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, 100 count bottle, Tablets
Amlodipine and Valsartan Tablets 5 mg/160 mg, 30 count bottle, Tablets
Amlodipine and Valsartan Tablets 10 mg/160 mg, 30 count bottle, Tablets
Amlodipine and Valsartan Tablets 5 mg/320 mg, 30 count bottle, Tablets
Amlodipine and Valsartan Tablets 10 mg/320 mg, 30 count bottle, Tablets
Valsartan and Hydrochlorothiazide tablets 320mg/12.5 mg, 90 count bottle, Tablets
Valsartan and Hydrochlorothiazide tablets 160mg/12.5 mg, 90 count bottle, Tablets
Valsartan and Hydrochlorothiazide tablets 320 mg/25 mg, 90 count bottle, Tablets
Valsartan and Hydrochlorothiazide tablets 80 mg/12.5 mg, 90 count bottle, Tablets
Valsartan and Hydrochlorothiazide tablets 160 mg/25 mg, 90 count bottle, Tablets
Valsartan tablets 320mg, 90 count bottle, Tablets
Cephalexin 250mg/5ml, Bottles, Oral Suspension
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/16/2019
Ceftriaxone for Injection 250mg, Single Use Vial Injection
Ceftriaxone for Injection 500mg, Single Use Vial Injection
Ceftriaxone for Injection 1G, Single Use Vial, Injection
Ceftriaxone for Injection 2G, Single Use Vial, Injection
Vecuronium Bromide, 10MG, Vials, Injection
Vecuronium Bromide, 20MG, Vials, Injection
OZURDEX (dexamethasone intravitreal implant) 0.7mg, Applicator, Implant
Estradiol Vaginal Inserts 10mcg, Cartons, Vaginal Inserts
Dianeal Low Calcium, 2.5mEq/L, Container bag, Solution
Cefdinir 125mg/5ml, Bottles, Oral Suspension
Cefdinir 250mg/5ml, Bottles, Oral Suspension
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 1ml, 5ml, Cartons, Syringe
Cidofovir Injection 375mg/4ml, 5ml vials, Injection
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
01/09/2019
Nitrofurantoin Oral Suspension 25mg/ml, 230ml bottle, Oral Suspension
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
FDA Recalls (Biologics)
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/recalls-biologics
FDA Recalls, Market Withdrawal Alerts
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Medicines Recommended for Disposal by Flushing
https://www.fda.gov/drugs/disposal-unused-medicines-what-you-should-know/drug-disposal-flush-potentially-dangerous-medicine#FlushList
Patient Safety Resource Center
https://www.ashp.org/Pharmacy-Practice/Resource-Centers/Patient-Safety
FDA Enforcement Report
FDA Recalls, Market Withdrawals and Safety Alerts
MediCal - Pay for Performance (P4P)
(IEHP) Pay for Performance program, also known as P4P. IEHP’s P4P was designed to increase the provision of preventive health services to IEHP Members as well as improve HEDIS® results to ensure that all IEHP Direct DualChoice Members receive timely annual assessment visits with an emphasis on review and management of chronic illnesses.
IEHP Direct PCPs will be reimbursed directly by IEHP through the DualChoice Annual Visit program. PCPs participating in IEHP's network through an IPA only are not eligible for this program:
Overview (PDF)
DualChoice Annual Visit (PDF)
To learn more about P4P IEHP DualChoice Annual Visit, contact a Provider Services Representative at (909) 890-2054.
Click on the following links to jump to that specific section:
Provider Quality Incentives Brochure
Medicare P4P IEHP Direct
IEHP Direct Stars Incentive Program
D-SNP Model of Care Incentive Program
Global Quality P4P Program
OB/GYN P4P Program
Hospital P4P Program
Provider Quality Incentives Brochure
Inland Empire Health Plan (IEHP) is pleased to announce the 2022 Provider Quality Incentive Brochure.
2022 Provider Quality Incentive Brochure (PDF) | June 22, 2022
(Back to P4P Menu)
Medicare P4P IEHP Direct Program
Inland Empire Health Plan (IEHP) is pleased to announce the Medicare P4P IEHP Direct Program. The goal of the program is designed to reward IEHP Direct Primary Care Providers (PCPs) for providing quality care to IEHP DualChoice Members.
Medicare P4P IEHP Direct Program Guide (PDF) Published: February 16, 2023
(Back to P4P Menu)
IEHP Direct Stars Incentive Program
Inland Empire Health Plan (IEHP) is pleased to announce the IEHP Direct Stars Incentive Program for Primary Care Physicians (PCPs). The goal of the program is to reward PCPs who provide high-quality care to IEHP DualChoice (HMO D-SNP) members.
IEHP Direct Stars Incentive Program Guide (PDF) Updated: March 23, 2023
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D-SNP Model of Care Incentive Program
Inland Empire Health Plan (IEHP) is pleased to announce the D-SNP Model of Care Incentive Program for Independent Physicians Associations (IPAs). The goal of the program is to reward IPAs who provide high-quality care to IEHP DualChoice (HMO D-SNP) members.
D-SNP Model of Care Incentive Program (PDF) Published: March 24, 2023
Chronic Care Improvement Program Planning and Reporting Document
The Chronic Care Improvement Program (CCIP) Planning and Reporting document can be used for the following D-SNP Model of Care Incentive Program activity: Chronic Care Improvement Program (CCIP) Activity.
CCIP Planning and Reporting Document (Word Document)
CCIP Planning and Reporting Document - Reference Guide (PDF)
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Global Quality P4P Program
If you would like more information about IEHP’s GQ P4P Program or best practices to help improve quality scores and outcomes, visit our Secure Provider Portal, email the Quality Team at QualityPrograms@iehp.org or call the IEHP Provider Relations Team at (909) 890-2054.
2023 IEHP Global Quality P4P Program Guide PCP (PDF) Published: March 14, 2023
2023 IEHP Global Quality P4P Program Guide IPA (PDF) Published: March 14, 2023
2022 IEHP Global Quality P4P Program Guide PCP (PDF) Published: December 21, 2022
2022 IEHP Global Quality P4P Program Guide IPA (PDF) Published: December 16, 2022
2022 Provider Quality Resource Guide (PDF) Published: July 14, 2022
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Quality Improvement Activity Strategy Forms
The Quality Improvement Activity (QIA) Strategy Forms can be used for the following 2023 and 2022 Global Quality P4P QIA Activities: Reducing Health Disparities and Potentially Avoidable Emergency Department Visits or Potentially Preventable Admissions.
2023 Equity Quality Improvement Activity #1 - Strategy Form (PDF)
2023 Quality Improvement Activity #2 - Strategy Form (PDF)
2022 Equity Quality Improvement Activity #1 - Strategy Form (PDF)
2022 Quality Improvement Activity #2 - Strategy Form (PDF)
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Potentially Avoidable Emergency Department (ED) Visits: Potentially Preventable Diagnosis Codes
The Potentially Preventable Diagnosis Code List includes diagnosis codes for visits to an ED in which the condition could be treated by a Physician or other health care Provider in a non-emergency setting or conditions that are potentially preventable or are ambulatory care sensitive.
Potentially Preventable Diagnosis List (PDF) Published: February 04, 2022
Patient Experience
This toolkit is full of proven tips and successful strategies based on the kinds of questions your IEHP Members could be asked to answer regarding their Provider's service. Your Provider Relations Team has targeted nine specific topics in this toolkit to help Providers and their staff continue to achieve the highest marks in Patient experience from their IEHP Members.
Serve Well Customer Service Toolkit (PDF)
Well Child
2021 Recommendations for Preventive Pediatric Health Care from the American Academy of Pediatrics (PDF)
Immunizations
IEHP provides vaccine coverage based on the latest ACIP recommendation and guidelines. Please refer to the Immunization Update and "Summary of Recommendations" for both Child and Adolescents AND Adult Vaccines as follows:
2022 Immunization Timing Chart - English (PDF)
2022 Immunization Timing Chart - Spanish (PDF)
2022 Immunization Timing Chart - Chinese (PDF)
2022 Immunization Timing Chart - Vietnamese (PDF)
Immunization Updates (PDF)
2021 Recommended Child and Adolescent Immunization Schedule (0-18 years) (PDF)
2021 Recommended Adult Immunization Schedule (19+ years) (PDF)
Adult Vaccines are a covered benefit and do not require prior authorization (must adhere to CDC/ACIP Immunization Recommendation and/or FDA approved indication).
Grow Well Childhood Immunization Toolkit for Providers (PDF)
This toolkit contains commonly used immunization codes, best practices for reporting immunizations including information on registering with CAIR, tips on talking with parents and information on understanding vaccination hesitancy.
CAIR2 Resource Guide (PDF)
This guide contains helpful links and contact information for locations to register for CAIR2 or current users.
Reimbursement process:
Complete a CMS1500 form by including the appropriate CPT codes, quantity dispensed and billed amount.
Mail:
IEHP Claims Department
P.O. Box 4349
Rancho Cucamonga, CA 91729-4349.
For the latest updates and news regarding the vaccines, please visit CDC's ACIP website at
https://www.cdc.gov/vaccines/hcp/acip-recs/index.html. By clicking on this link, you will be leaving the IEHP website.
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Quality Bonus Services Dispute Form
Please e-mail completed forms to QualityPrograms@iehp.org
Quality Bonus Service Dispute Request Form (PDF)
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OB/GYN P4P Program
Inland Empire Health Plan (IEHP) has released the OB/GYN P4P Program Guide which details the program requirements, performance measures, updated code sets, and payment timelines.
OB/GYN P4P Program Guide (PDF) Published: January 01, 2023
OB P4P Frequently Asked Questions FAQs (PDF) Published: February 13, 2023
Postpartum Depression Screening (PDF)
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Hospital P4P Program
Inland Empire Health Plan (IEHP) is pleased to announce the Hospital Pay For Performance Program (Hospital P4P) for IEHP Medi-Cal contracted Hospitals servicing Riverside and San Bernardino Counties. The goal of the Hospital P4P Program is to provide substantial financial rewards to Hospitals that meet quality performance targets and demonstrate high-quality care to IEHP Members.
2023 Hospital P4P Program Guide (PDF) Published: February 7, 2023
P4P 2023 MX Data Contributions (PDF) Published: February 02, 2023
IEHP P4P 2023 Data Guidelines (PDF) Published: February 02, 2023
2022 Hospital P4P Program Guide (PDF) Published: March 20, 2023
P4P 2022 MX Data Contribution (PDF) Published: April 18, 2022
P4P 2022 MX Data Guidelines (PDF) Published: April 18, 2022
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Potentially Avoidable Emergency Department (ED) Visits: Potentially Preventable Diagnosis Codes
The Potentially Preventable Diagnosis Code List includes diagnosis codes for visits to an ED in which the condition could be treated by a Physician or other health care Provider in a non-emergency setting or conditions that are potentially preventable or are ambulatory care sensitive.
Potentially Preventable Diagnosis List (PDF) Published: February 04, 2022
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Substance Use Disorders and Mental Health Diagnosis Lists
The Substance Use Disorders and Mental Health Diagnosis Lists includes diagnosis codes to identify substance use disorders, drug overdose, mental health or intentional self-harm diagnoses.
Mental Health Diagnosis List (PDF) Published: February 02, 2022
Substance Use Disorders Diagnosis List (PDF) Published: February 02, 2022
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You will need Adobe Acrobat Reader 6.0 or later to view the PDF files. You can download a free copy by clicking here