Recall D-0450-2025

US Class II Ongoing · initiated 2025-02-28

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05

Reason for recall

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

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