Drug product
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90
D-1175-2018
Product summary
- Event
- Event 80940
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19109 bottles
- Official record key
drug-enforcement:D-1175-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lots: 17325 Exp. 09/2018; 17856 Exp. 09/2018; 18396 Exp. 09/2018; 18702 Exp. 02/2019; 19020 Exp. 02/2019; 19222 Exp. 02/2019; 20030 Exp. 04/2019; 20381 Exp. 04/2019
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations