FDA-Drug2025-06-04Class II
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.
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
18,696 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., 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-0451-2025Don't want to check this manually?
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