Class IIReported 2025-01-01
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
Recalled by Glenmark Pharmaceuticals Inc., USA
Reason for Recall
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
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Recall NumberD-0159-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2024-12-11Reported2025-01-01DistributionUSA NationwideCode InfoLot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.