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FDAJanuary 22, 2025drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

glenmark pharmaceuticalsglenmark

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear