FDA-Drug2025-06-04Class II
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Sold states
U.S. Nationwide
Affected count
[100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0448-2025Don't want to check this manually?
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