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

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

Failed Content Uniformity Specifications

Class IIModerate

FDASep 2, 2025Nationwide• AvKARE

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

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Failed Impurities/Degradation Specifications:

Class IIILow

FDAAug 28, 2025Nationwide• Granules Pharmaceuticals Inc.

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