Recall D-0634-2025

US Class II Ongoing · initiated 2025-09-03

Recalling firm

Zydus Pharmaceuticals (USA) Inc, NJ

Product

Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1

Reason for recall

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

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