FDA-Drug2018-08-01Class II
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2317-19.
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
99,554 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2317-19.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0983-2018Don't want to check this manually?
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