D-0981-2018 Class II Ongoing
FDA drug recall D-0981-2018 was initiated by Teva Pharmaceuticals USA on Jul 16, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. The recall status is ongoing. Affected quantity: 56,603 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 1, 2018
- Initiation Date
- Jul 16, 2018
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0981-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026