Class IIReported 2024-12-11
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, 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 16714-554-01.
Recalled by Glenmark Pharmaceuticals Inc., USA
Reason for Recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Advertisement
Recall NumberD-0097-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2024-11-01Reported2024-12-11DistributionNationwide in the USACode InfoLot #: 17222452, Exp Date 11/30/2024; 17230607, Exp Date 02/28/2025.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.