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Showing 121–140 of 1310 results

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

Failed Impurity/Degradation Specifications

Class IIModerate

FDASep 4, 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 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

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

Viorele (Glenmark) – Impurity specification failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

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

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

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

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

Undeclared Allergen

undeclared allergen ingredient Milk.

Class IIModerate

FDASep 3, 2025Nationwide• New Spirit Naturals 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 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

Sulfamethoxazole and Trimethoprim (Major) – Foreign substance packaging (2025)

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDASep 2, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Norgestimate and Ethinyl Estradiol (AvKARE) – Content uniformity issue (2025)

Failed Content Uniformity Specifications

Class IIModerate

FDASep 2, 2025Nationwide• AvKARE

Aripiprazole Tablets (Ascend) – Superpotent drug risk (2025)

Superpotent drug

Class IIModerate

FDAAug 28, 2025Nationwide• Ascend Laboratories, LLC

Chlorpromazine Tablets (Amerisource) – Foreign Substance Detected (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

DermaMed Skin Ointment (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class IIModerate

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

Chlorpromazine Tablets (Amerisource) – Foreign substance packaging (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 27, 2025Nationwide• Amerisource Health Services LLC

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