Class IIReported 2025-04-09
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
Recalled by Glenmark Pharmaceuticals Inc., USA
Reason for Recall
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
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Recall NumberD-0309-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-03-11Reported2025-04-09DistributionNationwide in the USA and PRCode InfoLot#s: 17232222 and 17232237, Exp 10/31/2025Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.