D-0981-2018 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
- 56,603 bottles
Product Description
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19.
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
Lot # 1191191M, 1191192M, 1191193M, 1191194M, 1191195M, 1238466M, 1238467M, 1253261M 1256125M, 1277709M