FDA-Drug2025-08-20Class II
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05
Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Sold states
Nationwide in the USA
Affected count
4,800 bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0579-2025Don't want to check this manually?
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