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IEHP DualChoice - C 部分問題
決定，以取得醫療、行為健康或特定長期服務與支援（MSSP、CBAS 或 NF 服務） 如欲要求做出給付決定，請致電、來信或傳真給我們，或讓您的代表或醫師聯絡我們並要求做出給付決定。 您可以致電我們：(877) 273-IEHP (4347) 聯絡我們，服務時間為 (太平洋標準時間) 每天上午 8 點至晚上 8 點，假日亦提供服務，TTY 使用者請撥 (800) 718-4347。 您可以傳真至：(909) 890-5877 您可以來信至： IEHP DualChoice P.O.Box 1800 Rancho Cucamonga, CA 91729-1800。 C 部分服務的給付決定需要多長時間？ 在您提出請求後，處理時間通常需要最多 14 個曆日。若我們未於 14 個曆日內做出決定，您可以提出上訴。 有時我們需要更多時間做出決定，在此情況下，我們會寄信通知您，我們需要額外 14 個曆日的處理時間。信函會說明需要延長處理時間的原因。 我可以快點取得 C 部分服務的給付決定嗎？ 有。如果您因為健康情況而需要取得快速答覆，應要求我們做出「快速給付決定」。 若我們核准您的要求，我們會在 72 小時內告知您我們的給付決定。然而，有時我們需要更多時間做出決定，在此情況下，我們會寄信通知您，我們需要額外 14 個曆日的處理時間。 要求做出快速給付決定： 若您要求做出快速給付決定，可致電或傳真至本計畫，要求我們給付您想要的照護。 您可以致電 (877) 273-IEHP (4347) 與 IEHP DualChoice 聯繫，服務時間為太平洋標準時間每天上午 8 點至晚上 8 點，假日亦提供服務。TTY 使用者請撥 (800) 718-4347，或傳真至 (909) 890-5877。 您也可以要求您的醫師或代表致電我們。 以下為申請快速給付決定的規則： 您必須符合下列兩項要求才能獲得快速給付決定： 只有當您針對尚未取得的照護或用品提出給付要求時，才能獲得快速給付決定。(若您的要求是針對已取得的照護或用品，您將無法獲得快速給付決定。) 唯有當標準 14 個曆日截止期限可能會對您的健康造成嚴重傷害或損害您的身體機能時，才能獲得快速給付決定。 若您的醫師認為您需要快速給付決定，我們將自動為您做出快速給付決定。 如果您未取得醫師的支持即申請快速給付決定，將由我們決定您是否能獲得快速給付決定。 若我們認定您的健康狀況不符合快速給付決定之規定，我們會寄信通知您。我們仍將採用標準 14 個曆日截止期限。 該信函會告知您，如果您的醫師提出快速給付決定要求，我們將會自動做出快速給付決定。 該信函亦會說明，針對我們的快速給付決定並非您所要求的快速給付決定，您可以如何提出「快速上訴」。 如果給付決定為「核准」，那什麼時候可以取得服務或用品？ 您將能夠在提出申請後的 14 個曆日（標準給付決定）或 72 小時（快速給付決定）內取得服務或用品。如果我們延長了做出給付決定所需的期間，則將會在延長期間結束前提供給付。 如果給付決定為「拒絕」，我會如何得知？ 如果給付決定為「拒絕」，我們會寄信通知您，並說明拒絕的理由。 如果我們拒絕，您有權提出上訴，要求我們改變決定。提出上訴即代表要求我們審查拒絕給付的決定。 如果您決定提出上訴，表示您將進入第 1 階段上訴程序。 上訴 何謂上訴？ 上訴是您認為我們的決定有誤時，要求我們審查並變更給付決定的正式途徑。舉例來說，我們可能決定您所要求的任何服務、用品或藥品並未納入或已排除在 Medicare 或 Medi-Cal 給付範圍內。如果您或您的醫師不同意該決定，您可以提出上訴。 在大部分情況下，您都必須從第 1 階段上訴開始。若您不希望先就 Medi-Cal 服務計畫提出上訴，在特殊情況下，您可申請進行「獨立醫療審核」。若在上訴過程中需要協助，您可以致電 1-888-452-8609 與監察專員辦公室聯繫。監察專員辦公室與我方無關，也與任何保險公司或健康計畫無關。 C 部分服務的第 1 階段上訴是什麼？ 第 1 階段上訴係指對我們的計畫提出的第一次上訴。我們將審查給付決定，判定是否正確。審查人員將是未做出原始給付決定的人員。完成審查後，我們將以書面形式通知您裁決結果。如果我們在審查後，告知您該等服務或用品不在給付範圍內，則您可以提出第 2 階段上訴。 其他人可以代替我對 C 部分服務提出上訴嗎？ 有。您的醫師或其他提供者可以代替您提出上訴。另外，您的醫師或其他提供者以外的人員也可以代替您提出上訴，不過您必須先填寫「委任代表」表單。 該表單可授權其他人作為您的代表。 如果上訴是由您或您的醫師或其他提供者以外的人提出，我們必須先收到填寫完整的「委任代表」表單才能審查上訴。 如何對 C 部分服務提出第 1 階段上訴？ 若要開始上訴，您、您的醫師或其他提供者或您的代表必須與我們聯絡。您可以致電 (877) 273-IEHP (4347) 與 IEHP DualChoice 會員服務中心聯繫，服務時間為 (太平洋標準時間) 每天上午 8 點至晚上 8 點，假日亦提供服務。TTY 使用者請撥 (800) 718-4347。如需瞭解如何向我們提出上訴的其他詳細資訊，請參閱 IEHP DualChoice 會員手冊第 9 章。 您可以申請「標準上訴」或「快速上訴」。 如果您申請標準上訴或快速上訴，請以書面形式提出上訴並寄送至： IEHP DualChoice P.O.Box 1800 Rancho Cucamonga, CA 91729-1800 傳真：(909) 890-5748 您可以致電 (877) 273-IEHP (4347) 與 IEHP DualChoice 會員服務中心聯繫，提出上訴。服務時間為 (太平洋標準時間) 每天上午 8 點至晚上 8 點，假日亦提供服務。TTY 使用者請撥 (800) 718-4347。 我們將在收到您的上訴後 5 個曆日內發送信函給您，告知我們已收到您的上訴。 對 C 部分服務提出上訴的時間限制為何？ 您必須在我們向您發出告知決定的信函之日起 60 天內申請上訴。 如果您錯過此截止期限且可提供合理的理由，我們可能會給您更多時間提出上訴。以下是一些合理的理由範例：您當時患重病，或是我們為您提供了錯誤的申請上訴截止期限資訊。 我可以取得我的案例檔案副本嗎？ 有。若要申請副本，請致電 (877) 273-IEHP (4347) 與會員服務中心聯繫。TTY 使用者請撥 (800) 718-4347。 我的醫師可以提供有關我的 C 部分服務上訴的詳細資訊嗎？ 可以，您和您的醫師都可以提供佐證上訴的詳細資訊。 本計畫如何做出上訴裁決？ 我們會仔細審查有關您醫療照護給付申請的所有資訊。接著，我們會確認我們在拒絕您的申請時，是否遵守所有規定。審核人員將是未做出原始給付決定的人員。如果我們需要更多資訊，會要求您或您的醫師提供。 何時可以知道 C 部分服務「標準」上訴裁決結果？ 我們必須在接獲您的上訴後 30 個曆日內予以答覆。如果您的健康狀況需要，我們會儘快通知您我們的決定。 但是，若您要求更多時間，或我們需要收集更多資訊，則可能額外需要 14 個曆日的處理時間。如果我們認定需要多一些時間來做出決定，將會透過信函通知您。 如果您認為我們不應延長決定時間，您可以針對我們的決定提出「快速申訴」。若您提出「快速申訴」，我們將在 24 小時內就您的上訴予以答覆。 如果我們未在 30 個曆日內或延長期間 (如果採用) 結束後答覆您，且您的問題是與 Medicare 服務或用品有關，我們會自動將您的案例送交第 2 階段上訴程序。倘若發生此類情況，您將會收到通知。若您的問題是與 Medi-Cal 服務或用品有關，您將須自行提出第 2 階段上訴。詳情請參閱下列說明。 如果我們核准您的部分或全部要求，我們必須在收到您的上訴後 30 個曆日內核准或提供給付。 如果我們對於您所提要求的最後裁決是部分或全部拒絕，我們將會寄通知信函給您。若您的問題是與 Medicare 服務或用品有關，我們的信函將會通知您已將您的案例交付獨立審查單位進行第 2 階段上訴。若您的問題是與 Medi-Cal 服務或用品有關，我們的信函將告知您如何自行提出第 2 階段上訴。詳情請參閱下列說明。 如果申請快速上訴，會發生什麼？ 如果您申請快速上訴，我們會在收到您的上訴後 72 小時內予以答覆。如果您的健康狀況需要盡快取得裁決結果，我們會提早予以答覆。 但是，若您要求更多時間，或我們需要收集更多資訊，則可能額外需要 14 個曆日的處理時間。如果我們認定需要多一些時間來做出決定，將會透過信函通知您。 如果您認為我們不應延長決定時間，您可以針對我們的決定提出「快速申訴」。若您提出「快速申訴」，我們將在 24 小時內就您的上訴予以答覆。 如果我們未在 72 小時內或延長期間 (如果採用) 結束後答覆您，且您的問題是與 Medicare 服務或用品有關，我們會自動將您的案例送交第 2 階段上訴程序。倘若發生此類情況，您將會收到通知。若您的問題是與 Medi-Cal 服務或用品有關，您將須自行提出第 2 階段上訴。詳情請參閱下列說明。 如果我們核准您的部分或全部要求，我們必須在收到您的上訴後 72 小時內核准或提供給付。 如果我們對於您所提要求的最後裁決是部分或全部拒絕，我們將會寄通知信函給您。若您的問題是與 Medicare 服務或用品有關，我們的信函將會通知您已將您的案例交付獨立審查單位進行第 2 階段上訴。若您的問題是與 Medi-Cal 服務或用品有關，我們的信函將告知您如何自行提出第 2 階段上訴。詳情請參閱下列說明。 在第 1 階段上訴期間，我是否可繼續享有福利？如果我們決定變更或停止先前核准的任何服務或用品之給付，我們會在採取相關行動之前發送通知給您。如果您不同意該行動，可以提出第 1 階段上訴，並要求我們繼續為您提供相關服務或用品的福利。您必須在下列日期 (以發生時間較晚者為準) 之前提出申請，才能繼續享有福利： 在我們郵寄行動通知之日後 10 日內；或 行動的預計生效日期。 若您在前述截止期限內提出申請，則您在上訴期間仍可獲得爭議服務或用品的給付。 第 2 階段上訴 如果本計畫駁回我的第 1 階段上訴，接下來會發生什麼？如果我們對於您第 1 階段上訴的最後裁決是部分或全部拒絕，我們將會寄通知信函給您。該信函會告知您，相關服務或用品是否通常可獲得 Medicare 或 Medi-Cal 給付。 若您的問題是與 Medicare 服務或用品有關，我們會在第 1 階段上訴結束後，儘快自動將您的案例送交第 2 階段上訴程序。 若您的問題是與 Medi-Cal 服務或用品有關，您將須自行提出第 2 階段上訴。該信函會告知您如何進行。相關資訊也請參閱下方。 第 2 階段上訴是什麼？第 2 階段上訴係指第二次上訴，且係由與計畫無關的獨立組織進行。 我的問題與 Medi-Cal 服務或用品有關。我要如何提出第 2 階段上訴？針對 Medi-Cal 服務與用品提出第 2 階段上訴有兩種方式：1) 獨立醫療審核或 2) 州聽證會。 1) 獨立醫療審核 您可以向加州管理式醫療保健部 (California Department of Managed Health Care, DMHC) 協助中心申請獨立醫療審核 (IMR)。IMR 適用具醫療性質之所有 Medi-Cal 給付服務或用品。IMR 是由非本計畫成員之醫師審核您的案例。若 IMR 的裁決是您勝訴，則我們必須提供您所要求的服務或用品。您不須就 IMR 支付任何費用。 若本計畫符合下列條件，則您可以申請 IMR： 因本計畫認定不具醫療必要性，而駁回、變更或延遲提供 Medi-Cal 服務或治療 (不包括 IHSS)。 不就適用嚴重醫療狀況之實驗性或研究性 Medi-Cal 治療提供給付。 不支付您已經取得之緊急或急症 Medi-Cal 服務費用。 未於提出標準上訴後 30 個曆日內或於提出快速上訴後 72 小時內，解決您就 Medi-Cal 服務提起之第 1 階段上訴。 如果您還要求召開州聽證會，則您可以申請 IMR，惟僅限您未就相同問題召開過州聽證會。 在多數情況下，您必須在申請 IMR 之前提出上訴。如果您不同意我們的決定，您可要求 DMHC 協助中心進行 IMR。 若您的治療因為屬於實驗或研究性質而遭駁回，則您在申請 IMR 之前，不須參加我們的上訴程序。 如果您的問題具急迫性，且對您的健康具有迫在眉睫的嚴重威脅，您可以立即向 DMHC 提出申請。在特殊且急迫的狀況下，DMHC 得豁免您遵守我方上訴程序的規定。 您必須在我們書面通知您上訴裁決後 6 個月內申請 IMR。DMHC 可能在認定相關情況導致您無法準時提出申請時，接受您在前述 6 個月期間屆滿後提出的申請。 如欲申請 IMR： 請填寫獨立醫療審核/申訴表，網址為：http://www.dmhc.ca.gov/FileaComplaint/SubmitanIndependentMedicalReviewComplaintForm.aspx，或致電 (888) 466-2219 與 DMHC 協助中心聯繫。TDD 使用者請撥 (877) 688-9891。 請檢附我們駁回服務或用品申請之信函或其他文件 (若有)。如此可加快 IMR 流程。請寄送文件副本，而非正本。協助中心將不會退還任何文件。 如果您是由他人代表申請 IMR，請填寫「授權協助表」(Authorized Assistant Form)。此表格可於下列網址下載：http://www.dmhc.ca.gov/FileaComplaint/SubmitanIndependentMedicalReviewComplaintForm.aspx，或請致電 (888) 466-2219 與 DMHC 協助中心聯繫。TDD 使用者請撥 (877) 688-9891。 請郵寄或傳真您的表格及所有附件至： Help Center Department of Managed Health Care 980 Ninth Street, Suite 500 Sacramento, CA 95814-2725 傳真：916-255-5241 若您符合 IMR 資格，DMHC 將會在 7 個曆日內審核您的案例，並寄信通知您符合 IMR 規定。在從您的計畫收到您的申請表與佐證文件之後，IMR 將在 30 個曆日內做出決定。您應該會在提交完整申請資料後 45 個曆日內收到 IMR 裁決。 若您的案例具急迫性且您符合 IMR 資格，DMHC 將會在 2 個曆日內審核您的案例，並寄信通知您符合 IMR 規定。在從您的計畫收到您的申請表與佐證文件之後，IMR 將在 3 個曆日內做出決定。您應該會在提交完整申請資料後 7 個曆日內收到 IMR 裁決。 若您對 IMR 的裁決不滿意，仍可以要求召開州聽證會。 若 DMHC 認定您的案例不符合 IMR 規定，DMHC 將會透過一般消費者投訴程序審核您的案例。 2) 州聽證會 您可就 Medi-Cal 給付服務與用品申請召開州聽證會。若您的醫師或其他提供者要求提供我們不會核准的服務或用品，或我們不再繼續提供您已取得的服務或用品，且我們駁回您的第 1 階段上訴，則您有權申請召開州聽證會。 在大部分情況下，您有權在收到「您的聽證權利」通知後 120 天內，申請召開州聽證會。 注意：如果您申請召開州聽證會是由於我們告知您目前享有的服務即將變更或終止，而且您想要在召開州聽證會期間繼續享有該服務，則您提出申請的天數將縮減。有關詳細資訊，請參閱會員手冊第 9 章「在第 2 階段上訴期間，我是否可持續享有福利」。 申請召開州聽證會的方法有兩種： 您可以填寫行動通知背面的「申請召開州聽證會」。您應提供所有必要資訊，如您的全名、地址、電話號碼、計畫名稱或您遭採取行動之郡縣、相關補助計畫以及您希望申請召開聽證會的詳細理由。接著，您可以透過下列任一方式提交申請： 寄送至通知所載地址之郡縣福利部門。 寄送至 California Department of Social Services： State Hearings Division P.O.Box 944243, Mail Station 9-17-37 Sacramento, California 94244-2430 傳真至州聽證部門，號碼為 916-651-5210 或 916-651-2789。 您可以致電加州社會服務部，電話為 (800) 952-5253。TDD 使用者請撥 (800) 952-8349。若您決定透過電話申請召開州聽證會，您應瞭解該電話線路非常忙碌。 在第 2 階段上訴期間，我是否可繼續享有福利？若您的問題是與 Medicare 給付服務或用品有關，則在您向獨立審查單位提起第 2 階段上訴期間，您就服務或用品所享有的福利將不再繼續適用。 若您的問題是與 Medi-Cal 給付服務或用品有關，且您申請召開州公平聽證會，則在做出聽證決定之前，您就該服務或用品所享有的 Medi-Cal 福利將繼續適用。您必須在下列日期 (以發生時間較晚者為準) 之前申請召開聽證會，才能繼續享有福利： 在我們通知您已做出不適用福利裁決 (第 1 階段上訴裁決) 之郵寄日起 10 天內；或 行動的預計生效日期。 若您在前述截止期限內提出申請，則您在聽證會裁決做出之前仍可獲得爭議服務或用品的給付。 要如何得知裁決結果？若您的第 2 階段上訴為州聽證會，加州社會服務部將會寄函給您，說明裁決結果。 若州聽證會裁決為核准您申請的部分或全部項目，我們就必須遵守該裁決。我們必須在收到裁決副本之日起 30 個曆日內，完成規定之行動。 若州聽證會裁決為拒絕您申請的部分或全部項目，則表示其同意第 1 階段上訴裁決。我們可停止提供您所取得的任何暫時補助金。 若您的第 2 階段上訴為獨立醫療審核，管理式醫療保健部將會寄函給您，說明裁決結果。 若獨立醫療審核裁決為核准您申請的部分或全部項目，我們就必須提供服務或治療。 若獨立醫療審核裁決為拒絕您申請的部分或全部項目，則表示其同意第 1 階段上訴裁決。您仍可申請召開州聽證會。 若您的第 2 階段上訴係由 Medicare 獨立審查單位負責，該單位將會寄函給您，說明裁決理由。 若獨立審查單位的裁決為核准您申請的部分或全部項目，我們會在收到 IRE 裁決後的 72 小時內核准醫療照護給付，或在 14 個曆日內提供服務或用品。 若獨立審查單位的裁決為拒絕您申請的部分或全部項目，則表示其同意第 1 階段上訴裁決。此稱為「維持原裁決」；亦稱為「駁回上訴」。 如果裁決為拒絕我申請的全部或部分項目，我可以再次提出上訴嗎？若您的第 2 階段上訴為州聽證會，您可以在收到裁決後 30 天內申請複審。您也可以在收到裁決後一年內，向高等法院提交訴狀，申請對州聽證會駁回裁決進行司法審查 (依據民事訴訟法第 1094.5 條)。 若您的第 2 階段上訴為獨立醫療審核，您可以申請召開州聽證會。 若您的第 2 階段上訴係由 Medicare 獨立審查單位負責，則僅於您所申請服務或用品之價值符合特定最低金額門檻時，方可再次上訴。IRE 寄送給您的信函，將會說明您可能擁有的其他上訴權利。 付款問題 我們不允許網路內提供者向您收取給付服務與用品的費用。即使我們支付給提供者的金額低於提供者就給付服務或用品所收取的費用，也是如此。您絕對不需要支付任何帳單的差額。您唯一須支付的金額為規定應共付之服務、用品及/或藥品類別的共付額。若您收到的帳單金額高於您就給付服務與用品應支付的共付額，請將帳單寄給我們。您不應自行支付該帳單。我們會直接聯絡提供者並解決問題。 如果我支付了本計畫應付的醫療服務或用品分攤費用，如何向計畫申請退款？請記住，若您收到的帳單金額高於您就給付服務與用品應支付的共付額，您不應自行支付該帳單。但如果您支付了帳單，且您遵守服務和用品的取得規定，則您可以要求退款。 如果您要申請返款，就是申請給付裁決。我們將確認您所支付的服務或用品是否在給付範圍內，且我們將確認您是否遵守使用給付的規定。 如果您已付款的服務或用品屬於給付範圍，且您遵守所有規定，我們將會在收到您的申請後 60 個曆日內，將我們應支付的服務或用品分攤費用退還給您。 或者，如果您尚未支付該等服務或用品之費用，我們將會直接付款給您的提供者。若我們寄發款項，等同於我們同意您的給付裁決要求。 如果服務或用品不在給付範圍內，或是您未遵守所有規定，我們會郵寄信函通知您我們不會支付服務或用品費用並說明原因。 如果計畫表明不會付款，該怎麼辦？如果您不同意我們拒絕付款的決議，您可以提出上訴。遵循上訴程序。遵循這些指示時，請注意： 若您提出報銷上訴，我們必須在接獲上訴後 60 個曆日內回覆。 若您要求我們返還您已自費接受之醫療照護的費用，則不得申請快速上訴。 若我們對您上訴的答覆為「拒絕」，且該等服務或用品通常可獲得 Medicare 給付，我們將自動將您的案例發送給獨立審查單位。若有此情況，我們會寄通知函給您。 若 IRE 駁回我方裁決並認定我們應付款，則我們必須於 30 個日曆日內付款給您或提供者。如果您的上訴在第 2 階段上訴程序後的任何階段中獲得核准，我們必須在 60 個日曆日內寄發您要求的款項給您或提供者。 若 IRE 駁回您的上訴，表示他們同意我們的裁決，即不批准您的要求。(這稱為「維持原裁決」；亦稱為「駁回上訴」)。您所收到的信函，將會說明您可能擁有的其他上訴權利。僅於您所申請服務或用品之價值符合特定最低金額門檻時，方可再次上訴。 若我們對您上訴的答覆為「拒絕」，且該等服務或用品通常可獲得 Medi-Cal 給付，則您可自行提出第 2 階段上訴 (請參閱上文)。 IEHP DualChoice (HMO D-SNP) 是與 Medicare 簽約的 HMO 計畫。投保 IEHP DualChoice (HMO D-SNP) 取決於合約續訂。 此頁面資訊為截至 2022 年 10 月 1 日的最新資訊。 H8894_DSNP_23_3241532_M Pending Accepted
IEHP DualChoice - D 部分問題
部分藥品」。部分藥品不在 Medicare D 部分給付範圍內，但 Medi-Cal 可能會給付。 我可以針對 D 部分處方藥要求給付裁決或提出上訴嗎？ 可以。以下為您可向我們提出 D 部分藥品給付裁決要求的範例。 您要求我們做出例外安排，例如： 要求我們給付不在本計畫「給付藥品清單 (處方集)」中的 D 部分藥品 要求我們免除計畫對藥品給付的限制 (例如可取得藥品的數量) 您向我們詢問某一藥品是否在您的給付範圍內 (例如，您的藥品列於本計畫的處方集中，但我們規定您必須先獲得核准，我們才會給付該藥品)。 請注意：如果藥局告知您可能無法領取所需的處方藥，您將會收到一份通知，說明如何與我們聯繫以申請給付裁決。 您可以要求我們支付您已購買的處方藥費用。亦即要求關於付款的給付裁決。 如果您不同意我們所做的給付決定，可以針對我們的決議提出上訴。 例外狀況是指什麼？ 例外情況是指允許給付通常不在給付藥品清單中的藥物，或是允許在不需遵守特定規定與限制的情況下使用藥物。若藥物未列於我們的給付藥品清單中，或者給付條件與您的期望不符，您可以要求我們以「例外情況」處理。 若您提出例外申請，您的醫師或其他開立處方者須說明您需要該例外的醫療原因。 以下範例說明您、您的醫師或其他開立處方者可提出的例外申請： 給付未列於給付藥品清單 (處方集) 中的 D 部分藥品。 如果我們同意做出例外安排，並給付未列於處方集中的藥品，您將需要支付適用於藥物的藥品分攤費用。 您不得就我方要求您支付的藥品共同負擔費用或共同保險費用金額提出例外要求。 解除給付限制。我們處方集上的某些特定藥品必須遵守額外的規定或限制。 針對特定藥品的額外給付規定和限制包括： 須使用藥品的學名藥，而非原廠藥。 在我們同意為您給付該藥品前，事先取得計畫核准。(有時稱為「事先授權」)。 在我們同意為您給付要求的藥品前，需先嘗試另外一種藥品。(有時稱為「分階段療法」)。 數量限制。計畫有時會針對某些藥品限制您可以取得的藥品數量。 如果我們同意做出例外安排並免除對您的限制，您可以針對我們要求您支付的藥品共同負擔費用金額提出例外申請。 提出破例申請的重要須知 您的醫師或其他開立處方者必須向我們提供聲明，解釋提出破例申請的醫療因素。若您在提出例外申請時隨附開立處方者提供的這項資訊，可以更快知道例外裁決的結果。 通常，我們的處方集包含一種以上用於治療特定病症的藥品。這些不同的選擇稱為「替代」藥品。若替代藥品和您所申請的藥品具有相同療效，並且也不會引發更多副作用或其他健康問題，我們通常不會核准您的例外申請。 我們將核准或拒絕您的例外申請。 若我們核准您的例外申請，則例外處理的有效期限通常持續到當曆年的年底。只要您的醫師持續為您開立該藥品的處方，且該藥品可持續安全有效地治療您的症狀，情況即不會發生改變。 如果我們拒絕您的例外申請，您可以提出上訴，要求針對我們的決議進行審查。 給付決定 具體做法 申請您所需要的給付決定類型。以致電、寄信或傳真方式向我們提出申請。您、您的代表或您的醫師（或其他開立處方者）皆可提出申請。 您可以致電我們：電話 (877) 273-IEHP (4347)，服務時間為 (太平洋標準時間) 每天上午 8 點至晚上 8 點，假日亦提供服務。TTY 使用者請致電 1-800-718-4347。 您可以傳真至：(909) 890-5877 您可以來信至： IEHP DualChoice P.O. Box 1800 Rancho Cucamonga, CA 91729-1800 您、您的醫師 (或其他開立處方者) 或您的代表皆可申請給付決定。您也可以委由律師代表您提出申請。 您的醫師或其他開立處方者不需要您的書面授權即可代表您向我們申請給付裁定。 若您提出例外申請，請提供「佐證聲明」。您的醫師或其他開立處方者必須向我們提供聲明，說明提出藥品例外申請的醫療原因。我們稱之為「佐證聲明」。 您的醫師或其他開立處方者可以將聲明傳真或郵寄給我們。您的醫師或其他開立處方者亦可先來電告知我們，然後再將聲明傳真或郵寄給我們。 申請 Medicare 處方藥給付裁定 (PDF) 此表單亦可透過 CMS 網站取得： Medicare 處方藥裁定申請表（適用於投保人與提供者） 點選此連結，您將會離開 IEHP DualChoice 網站。 您尚未取得之藥品的「標準給付決定」截止期限 若我們採用標準截止期限，我們必須在收到您的申請後 72 小時內回覆；若您申請例外，則在我們收到您的醫師或開立處方者的佐證聲明後 72 小時內回覆。如果您的健康狀況需要，我們會儘快予以回覆。 若我們無法滿足此截止期限，我們會將您的申請送交第 2 階段上訴程序。在第 2 階段上訴程序中，將由獨立審查單位審查我們的決定。 如果我們核准您的部分或全部要求，我們必須在您提出申請後 72 小時內批准或給付；若您申請例外，則我們必須在收到您的醫師或開立處方者的佐證聲明後 72 小時內處理。 如果我們拒絕您的部分或全部要求，我們會寄信通知您，並說明駁回原因。通知函中亦會註明如何針對我們的裁決提出上訴。 您已購買之藥品的「標準給付決定」截止期限 我們必須在收到您的申請後 14 個曆日內答覆您。 若我們無法滿足此截止期限，我們會將您的申請送交第 2 階段上訴程序。在第 2 階段上訴程序中，將由獨立審查單位審查我們的決定。 如果我們核准您的部分或全部要求，我們會在 14 個曆日內付款給您。 如果我們拒絕您的部分或全部要求，我們會寄信通知您，並說明駁回原因。通知函中亦會註明如何針對我們的裁決提出上訴。 如果您的健康狀況需要，可以要求我們做出「快速給付決定」 除非我們已同意採用「快速截止期限」，否則我們會以「標準截止期限」為準。 標準給付決定表示我們將在收到您的醫師聲明後的 72 小時內給您答覆。 快速給付決定表示我們將在收到您的醫師聲明後的 24 小時內給您答覆。 唯有在您針對尚未領取的藥品提出申請的情況下，才能獲得快速給付決定。(若您是要求我們返還您已支付的藥品費用，則無法申請快速給付決定)。 唯有當採用標準截止期限可能會對您的健康造成嚴重傷害或損害您的身體機能時，才能獲得快速給付決定。 如果您的醫師或其他開立處方者告知我們，您的健康情況需取得「快速給付決定」，我們將自動同意做出快速給付決定，並將寄送信函通知您。 如果您自行提出快速給付決定申請 (未提供您的醫師或其他開立處方者的聲明)，我們將決定您是否適用快速給付決定。 如果我們決定您的醫療狀況不符合快速給付決定要求，我們將採用標準截止期限。 我們會郵寄信函通知您。信函將說明您如何針對我們的標準給付決定提出申訴。 您可以提出「快速申訴」，24 小時內即可得知結果。 「快速給付決定」的截止期限 如果我們採用快速截止期限，就必須在 24 小時內給您答覆。亦即在我們收到您的申請後 24 小時內。若您申請例外，則我們將在收到您的醫師或開立處方者的聲明後 24 小時內答覆您。如果您的健康狀況需要，我們會儘快答覆您。 若我們無法滿足此截止期限，我們會將您的申請送交第 2 階段上訴程序。在第 2 階段上訴程序中，將由外部獨立組織審核您的申請及我們的決定。 如果我們核准您的部分或全部要求，我們必須在收到您的申請或您的醫師或開立處方者的佐證聲明後 24 小時內答覆您。 如果我們拒絕您的部分或全部要求，我們會寄信通知您，並說明駁回原因。通知函中亦會註明如何針對我們的裁決提出上訴。 D 部分藥品第 1 階段上訴 若要開始上訴，您、您的醫師或其他提供者，或您的代表必須與我們聯絡。 如果要申請標準上訴，您可透過發送書面申請的方式提出上訴。您亦可致電 1-877-273-IEHP (4347) 與 IEHP DualChoice 會員服務中心聯繫，提出上訴。服務時間為 (太平洋標準時間) 每天上午 8 點至晚上 8 點，假日亦提供服務。TTY/TDD 使用者請撥 1-800-718-4347。 若要申請快速上訴，可以透過寫信或致電的方式申請。 您必須在我們發出給付決定通知之日起 60 個曆日內提出上訴。若有正當理由未在該截止期限內提出申請，我們可以延長提出上訴的時間。 舉例來說，錯過截止期限的正當理由可能包含：您當時患重病而無法聯絡我們，或是我們提供的申請上訴截止期限資訊不正確或不完整。 您可以申請一份上訴資訊副本並新增更多資訊。 您有權要求我們提供有關您上訴的資料副本。 若有意願，您及您的醫師或其他開立處方者可向我們提供附加資訊以支援您上訴。 您可以使用下列表單提出上訴： 給付裁決表單 (PDF) 其他人可以代替我提出上訴嗎？可以。您的醫師或其他提供者可以代替您提出上訴。另外，您的醫師或其他提供者以外的人員也可以代替您提出上訴，不過您必須先填寫「委任代表」表單。該表單可授權其他人作為您的代表。 如果上訴是由您或您的醫師或其他提供者以外的人提出，我們必須先收到填寫完整的「委任代表」表單才能審查上訴。 「標準上訴」的截止期限 若我們採用標準截止期限，必須在收到上訴申請後 7 個曆日內答覆您，如果您的健康狀況需要，也可以提早答覆。若對您的健康有必要，請申請「快速上訴」。若您要求我們就您已購買之藥品退款給您，我們必須在收到您的上訴後 14 個曆日內答覆您。 若我們未在 7 個曆日 (或若您要求我們就您已購買之藥品退款給您，則為 14 個曆日) 內答覆您，我們會將您的申請送交第 2 階段上訴程序。在第 2 階段上訴程序中，將由獨立審查單位審查我們的決定。 若對您的健康有必要，請申請「快速上訴」 如果您針對我們就您尚未取得之藥品給付決定提出上訴，您與您的醫師或其他開立處方者需決定您是否需要「快速上訴」。 申請「快速上訴」的要求同於申請「快速給付決定」。 我們的計畫將審核您的上訴並做出裁決 我們會再次仔細審查與您的給付申請相關的所有資訊。我們會確認在拒絕您的申請時是否遵守所有規定。我們可能會聯絡您、您的醫師或其他開立處方者以獲得更多資訊。 「快速上訴」的截止期限 若我們採用快速截止期限，會在收到上訴申請後 72 小時內答覆您，如果您的健康狀況需要，也可以提早答覆。 若我們未在 72 小時內答覆您，我們會將您的申請 送交第 2 階段上訴程序。在第 2 階段上訴程序中，將由獨立審查單位審查您的上訴。 如果我們核准您的部分或全部要求，必須在收到上訴申請後 72 小時內進行給付。 如果我們拒絕您的部分或全部要求，我們會寄信通知您，並說明駁回原因。 D 部分藥品第 2 階段上訴 如果我們駁回您的上訴，您可以選擇接受裁決或再次提起上訴。若您決定提出第 2 階段上訴，將會由獨立審查單位審查我們的裁決。 若您希望由獨立審查機構審查您的案例，必須以書面方式提出上訴。 請在您收到裁決通知後的 60 天內提出上訴。如果您錯過此截止期限，但只要能提供合理解釋，仍可提出上訴。 您、您的醫師或其他開立處方者或您的代表都可以提出第 2 階段上訴。 若您向獨立審查單位提出上訴，我們會將您的案例相關檔案寄給對方。您有權要求我們提供一份案例檔案的副本給您。您有權向獨立審查單位提供其他對上訴有利的資訊。獨立審查單位是由 Medicare 聘僱的獨立機構，與本計畫無關聯，且非政府機構。獨立審查單位的審查人員會仔細審查所有與上訴相關的資訊。之後，該機構會寄函給您，說明其裁決結果。 若我們在重新判定後仍維持拒絕裁定，您有權申請复議。請參閱下列表單： 复議申請表 (PDF) 第 2 階段上訴之「快速上訴」截止期限如果您的健康狀況需要，可要求獨立審查單位進行「快速上訴」。 若審查機構同意進行「快速上訴」，其必須在接獲上訴申請後 72 小時內回覆關於第 2 階段上訴的結果。 若獨立審查單位核准您的部分或全部要求，我們必須於接獲裁決後 24 小時內授權或給付您所申請的藥品。 第 2 階段「標準上訴」的截止期限若您申請第 2 階段標準上訴，獨立審查單位必須在收到上訴申請後 7 個曆日內回覆關於第 2 階段上訴的結果。 若獨立審查單位核准您的部分或全部要求，我們必須於接獲裁決後 72 小時內授權或給付您所申請的藥品。 若獨立審查單位核准返還您已購買之藥品費用的要求，我們會在收到裁決後 30 個曆日內付款。 如果獨立審查單位駁回您的第 2 階段上訴會怎樣？駁回表示獨立審查單位同意我們不核准您的申請的決定。此稱為「維持原裁決」；亦稱為「駁回上訴」。 若您申請給付的藥品價值符合特定最低金額門檻，您可提出第 3 階段上訴。獨立審查單位寄給您的信函中，將會說明繼續提出上訴所須符合的金額門檻。第 3 階段上訴是由行政法官負責受理。 如需詳細資訊，請參閱您的 IEHP DualChoice 會員手冊第 9 章。 IEHP DualChoice (HMO D-SNP) 是與 Medicare 簽約的 HMO 計畫。投保 IEHP DualChoice (HMO D-SNP) 取決於合約續訂。 此頁面資訊為截至 2022 年 10 月 1 日的最新資訊。 H8894_DSNP_23_3241532_M Pending Accepted
Safety Resources - 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
Provider Resources - 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.
P4P - Proposition 56 - GEMT - 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
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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
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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: March 23, 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