FDA-Drug2018-08-01Class II
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
MAJOR PHARMACEUTICALS
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
Nationwide.
Affected count
5,464 cartons
Manufactured in
17177 N Laurel Park Dr, N/A, Livonia, MI, United States
Products
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0966-2018Don't want to check this manually?
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