FDA-Drug2018-09-05Class II
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
AVKARE Inc.
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
U.S. Nationwide
Affected count
728 cartons (36,400 tablets)
Manufactured in
615 N 1st St, N/A, Pulaski, TN, United States
Products
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1131-2018Don't want to check this manually?
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