Recall D-0216-2025

US Class II Ongoing · initiated 2025-01-22

Recalling firm

Glenmark Pharmaceuticals Inc., USA, NJ

Product

Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.

Reason for recall

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

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