D-0989-2018 Class II Ongoing
FDA drug recall D-0989-2018 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: 13,555 90-count bottles; 2,892 500-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 1, 2018
- Initiation Date
- Jul 16, 2018
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0989-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026