Drug product
Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
D-1096-2018
Product summary
- Event
- Event 80703
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43 bottles
- Official record key
drug-enforcement:D-1096-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot: UTB23790003, exp 02/28/2019
Distribution pattern: Indiana
Derived failure modes
-
Manufacturing or process control
CGMP Deviations