Recalls / Class II
Class IID-0984-2018
Product
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 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 0591-2318-19
- Affected lot / code info
- Lot Numbers: 1191185M, 1191186M, 1225615M, 1233948M, 1250718M, 1253257M
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 64,168 bottles
- Distribution pattern
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
Timeline
- Recall initiated
- 2018-07-16
- FDA classified
- 2018-07-24
- Posted by FDA
- 2018-08-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0984-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.