FDA-Drug2018-08-01Class II
Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
Teva Pharmaceuticals USA
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Affected count
13,555 90-count bottles; 2,892 500-count bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0989-2018Don't want to check this manually?
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