Drug product
Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
D-1107-2018
Product summary
- Event
- Event 80840
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 bottles consisting of 90 tables each bottle
- Official record key
drug-enforcement:D-1107-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot # G2017F NDC 68788-6882-9
Distribution pattern: Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations