Recalls / Class II

Class IID-0988-2018

Product

Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

Affected lot / code info

NDC 0591-2169-19 Lot Numbers: 1177880A, 1220831A, 1263941A NDC 0591-2169-10 1175922M, 1220826M, 1236294M, 1240427M, 1270616A

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

15,347 90-count bottles, 8,378 1000-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-0988-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.