D-1133-2018 Class II Terminated
FDA drug recall D-1133-2018 was initiated by AVKARE Inc. on Aug 14, 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 terminated (terminated May 7, 2020). Affected quantity: 1496 cartons (44,880 tablets).
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 5, 2018
- Initiation Date
- Aug 14, 2018
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1496 cartons (44,880 tablets)
Product Description
Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution Pattern
U.S. Nationwide
Code Information
Lots: 17718 Exp. 07/2018; 18700 Exp. 01/2019; 19133 Exp. 02/2019; 19532 Exp. 04/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1133-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026