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Zydus Pharmaceuticals (USA) Inc Recall: chlorproMAZINE Hydrochloride Tablets, USP 10 mg, R

Zydus Pharmaceuticals (USA) Inc Recall: chlorproMAZINE Hydrochloride Tablets, USP 10 mg, R is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Zydus Pharmaceuticals (USA) Inc; Product: chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lif

Recalling firmZydus Pharmaceuticals (USA) Inc
ProductchlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
Reason for recallCGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionNationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
Recall initiated20250403
Recall numberD-0361-2025
Categorydrug
StateNJ
CountryUnited States

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