FDA-Drug2025-02-12Class II
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Sold states
Nationwide in the U.S
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0215-2025Don't want to check this manually?
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