FDA-Drug2025-08-27Class II
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Sold states
Product was distributed nationwide within the United States.
Affected count
26,628 cartons
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
Products
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0594-2025Don't want to check this manually?
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