Recalls / Class II

Class IID-0986-2018

Product

Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

Affected lot / code info

Lot Numbers: NDC 0591-2167-30 1196936A, 1238463A, 1270617A NDC 0591-2167-19 1196934M, 1238462M, 1268429A

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

8,046 30-count bottles, 20,841 90-count 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-0986-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.