Drug product
Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
D-1095-2018
Product summary
- Event
- Event 80703
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68 bottles
- Official record key
drug-enforcement:D-1095-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot: UT48320002, exp 07/31/2018; Lot UT48320003, exp 05/31/2019
Distribution pattern: Indiana
Derived failure modes
-
Manufacturing or process control
CGMP Deviations