Class IIReported 2024-12-11
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.
Recalled by Glenmark Pharmaceuticals Inc., USA
Reason for Recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
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Recall NumberD-0095-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2024-11-01Reported2024-12-11DistributionNationwide in the USACode InfoLot #: 17222470, 17230680, 17222547, Exp. Date 11/30/2024; 17230304, Exp. Date, 12/31/2024; 17230598, Exp. Date, 02/2025.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.