FDA-Drug2025-08-20Class II
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
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
44,328 bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0577-2025Don't want to check this manually?
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