Drug product
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
D-1021-2018
Product summary
- Event
- Event 80646
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 HDPE 90-count bottles (270 tablets)
- Official record key
drug-enforcement:D-1021-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot # B0383153-122917; Exp. 12/18
Distribution pattern: Product was distributed to 3 medical facilities in Florida.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations