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Showing 361–380 of 1571 results

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Testosterone Cypionate Injection (Eugia US LLC) – Crystal Dissolution Issue (2025)

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Class IIModerate

FDAApr 10, 2025Nationwide• Eugia US LLC

Levothyroxine Sodium Tablets (Accord Healthcare) – Subpotent Medication (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine 50mcg (ACCORD) – Subpotent (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine 88mcg (ACCORD) – Subpotent (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets (Accord Healthcare) – Subpotent Medication (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Hemopropin Ointment (Apipharma) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAApr 9, 2025AZ• Apipharma

Wegovy (Cardinal Health) – Temperature Storage Abuse (2025)

Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.

Class IIModerate

FDAApr 9, 2025NC, SC, VA• Cardinal Health Inc.

Kapsin Ointment (Apipharma) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAApr 9, 2025AZ• Apipharma

ChlorproMAZINE Tablets (Zydus) – Impurity Above Limit (2025)

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Class IIModerate

FDAApr 3, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Haloperidol Decanoate Injection (Amerisource) – Sterility Risk (2025)

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Class IIModerate

FDAApr 2, 2025Nationwide• Amerisource Health Services LLC

Haloperidol Decanoate Injection (Amerisource) – Sterility Risk (2025)

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Class IIModerate

FDAApr 2, 2025Nationwide• Amerisource Health Services LLC

Haloperidol Decanoate Injection (Amerisource) – Sterility Risk (2025)

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Class IIModerate

FDAApr 2, 2025Nationwide• Amerisource Health Services LLC

Dexmedetomidine HCl (Denver Solutions) – Leaking Syringes (2025)

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class IIModerate

FDAMar 31, 2025Nationwide• Denver Solutions, LLC DBA Leiters Health

Rocuronium Bromide (Denver Solutions) – Leaking Syringes (2025)

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class IIModerate

FDAMar 31, 2025Nationwide• Denver Solutions, LLC DBA Leiters Health

Glycopyrrolate (Denver Solutions) – Leaking Syringes (2025)

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class IIModerate

FDAMar 31, 2025Nationwide• Denver Solutions, LLC DBA Leiters Health

Ketamine HCl (Denver Solutions) – Leaking Syringes (2025)

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class IIModerate

FDAMar 31, 2025Nationwide• Denver Solutions, LLC DBA Leiters Health

Phenylephrine HCl (Denver Solutions) – Leaking Syringes (2025)

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class IIModerate

FDAMar 31, 2025Nationwide• Denver Solutions, LLC DBA Leiters Health

Unisom SleepMinis (Chattem) – Nitrosamine Impurity (2025)

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

Class IIModerate

FDAMar 26, 2025Nationwide• Chattem Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

Class IIModerate

FDAMar 26, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Clindamycin HCl Capsules (RemedyRepack) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 24, 2025PA• RemedyRepack Inc.

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