D-0989-2018 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 1, 2018
- Initiation Date
- July 16, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,555 90-count bottles; 2,892 500-count bottles
Product Description
Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution Pattern
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Code Information
NDC 0591-2170-19 Lot Numbers: 1208002A, 1247282M, 1263944M NDC 0591-2170-05 Lot Numbers: 1208000M, 1208001M, 1240425A