D-1177-2018 Class II Terminated
FDA drug recall D-1177-2018 was initiated by Avkare Incorporated on July 18, 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: 19623 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 12, 2018
- Initiation Date
- July 18, 2018
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19623 bottles
Product Description
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution Pattern
Nationwide
Code Information
Lots: 17308 Exp. 09/2018; 18158 Exp. 09/2018; 18539 Exp. 01/2019; 19021 Exp. 01/2019; 19225 Exp. 01/2019; 20033 Exp. 06/2019; 20290 Exp. 06/2019; 20565 Exp. 06/2019; 21369 Exp. 10/2019