Recall D-0095-2025

US Class II Ongoing · initiated 2024-11-01

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

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.

Reason for recall

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

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