FDA Drug Moderate Class II Ongoing

Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054

Reported: August 1, 2018 Initiated: July 16, 2018 #D-0987-2018

Product Description

Reason for Recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Details

Recalling Firm: Teva Pharmaceuticals USA
Units Affected: 30,793 90-count bottles, 1,158 1000-count bottles
Distribution: Product was distributed throughout the United States, including Hawaii and Puerto Rico
Location: North Wales, PA

Frequently Asked Questions

What product was recalled? ▼

Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. Recalled by Teva Pharmaceuticals USA. Units affected: 30,793 90-count bottles, 1,158 1000-count bottles.

Why was this product recalled? ▼

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 1, 2018. Severity: Moderate. Recall number: D-0987-2018.