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FDA (Drug enforcement)Recalled 2025-09-03class ii

Zydus Pharmaceuticals (USA) Inc: Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuti

Hazard

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

Details from the source

Reason for recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit Distribution: Nationwide in the USA Quantity: N/A Lot/code info: Lot #: Z305083, Z305084, Z305468, Z305469, Z305470, Exp Date 30-09-25; Z401163, Z401165, Exp Date 28-02-26; Z402217, Z402218, Exp Date 31-03-26; Z405518, Z405520, Exp Date 31-08-26; Z406235, Exp Date 31-10-26

Source

Official record: FDA (Drug enforcement)

Republished from the official source above; details can change — the source record controls.

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