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Showing 301–320 of 1310 results

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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

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

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.

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

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

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

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

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

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Methocarbamol Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Venlafaxine Tablets (Zydus) – Foreign Material Risk (2025)

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

Class IIModerate

FDAMar 21, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

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

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Atorvastatin Tablets (Biocon) – Dissolution Failure (2025)

Failed dissolution specifications: lower than specifications

Class IIModerate

FDAMar 17, 2025Nationwide• BIOCON PHARMA INC

Indomethacin Extended-Release Capsules 75mg (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Voriconazole Tablets 50mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Solifenacin Succinate Tablets (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Gabapentin Tablets 600mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Nitroglycerin Sublingual Tablets 0.4mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Frovatriptan Succinate Tablets 2.5mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Prochlorperazine Maleate Tablets (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

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