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Showing 141–160 of 1639 results

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Brimonidine/Timolol Ophthalmic Solution (Apotex) – sterility concern (2025)

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Class IIModerate

FDASep 5, 2025Nationwide• Apotex Corp.

Ketorolac Tromethamine Eye Drops (Apotex) – sterility concern (2025)

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Class IIModerate

FDASep 5, 2025Nationwide• Apotex Corp.

Everolimus Tablets (Endo USA) – impurity specification failure (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Class IIILow

FDASep 5, 2025Nationwide• Endo USA, Inc.

Cyclophosphamide Injection (Sandoz) – temperature excursion (2025)

cGMP deviations: Temperature excursion during transportation.

Class IIModerate

FDASep 5, 2025Nationwide• Sandoz Inc

Entecavir Tablets 1mg (Zydus) – impurity specification failure (2025)

Failed Impurity/Degradation Specifications

Class IIModerate

FDASep 4, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

FemiClear Daily Bladder Strength (Organicare) – Microbial Contamination (2025)

Microbial contamination with Escherichia coli O7:K1 and E. Coli 1303.

Class IIModerate

FDASep 4, 2025IN, PR• Organicare Nature's Science, LLC

Entecavir Tablets 0.5mg (Zydus) – impurity specification failure (2025)

Failed Impurity/Degradation Specifications

Class IIModerate

FDASep 4, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Gluta Plus (New Spirit) – Undeclared Milk (2025)

Undeclared Allergen

undeclared allergen ingredient Milk.

Class IIModerate

FDASep 3, 2025Nationwide• New Spirit Naturals Inc.

Chlorpromazine Hydrochloride 100mg Tablets (Zydus) – N-Nitroso impurity (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

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

Chlorpromazine Hydrochloride Tablets (Zydus) – CGMP impurity risk (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

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

Chlorpromazine Hydrochloride Tablets (Zydus) – CGMP impurity risk (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

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

Viorele (Glenmark) – Impurity specification failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDASep 3, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Chlorpromazine Hydrochloride 25mg Tablets (Zydus) – N-Nitroso impurity (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

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

Technetium Tc 99m Mertiatide Kit (Sun Pharmaceutical) – dissolution specification failure (2025)

Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.

Class IIModerate

FDASep 3, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Chlorpromazine Hydrochloride 10mg Tablets (Zydus) – N-Nitroso impurity (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

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

Chlorpromazine Hydrochloride 50mg Tablets (Zydus) – N-Nitroso impurity (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

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

Chlorpromazine Hydrochloride Tablets (Zydus) – CGMP impurity risk (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

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

Chlorpromazine Hydrochloride Tablets (Zydus) – CGMP impurity risk (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

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

Chlorpromazine Hydrochloride Tablets (Zydus) – CGMP impurity risk (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

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

Chlorpromazine Hydrochloride 50mg Tablets (Zydus) – N-Nitroso impurity (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

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

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