Valsartan Tablets recall: Impurity Out of Spec
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
Why was Valsartan Tablets recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: NDC 0591-2168-19 1175947M, 1175948M, 1177115A, 1219361A, 1240434M, 1250704M NDC 0591-2168-10 1177114A, 1219360M, 1250706A
- Product
- 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
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 30,793 90-count bottles, 1,158 1000-count bottles
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Recall date
- August 1, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)