Recall D-0451-2025

US Class II Ongoing · initiated 2025-02-28

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.

Reason for recall

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

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