Class IIReported 2024-12-11
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.
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-0098-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2024-11-01Reported2024-12-11DistributionNationwide in the USACode InfoLot #:17222547, Exp. Date, 11/30/2024; 17230598, Exp. Date 02/28/2025Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.