Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.
Reason
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Classification
Class II
Status
Ongoing
Lot
Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025
Date
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