Drug product
Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)
D-0660-2016
Product summary
- Event
- Event 73166
- Status
- Terminated
- Classification
- Class III
- Quantity
- 716 cartons
- Official record key
drug-enforcement:D-0660-2016
Official wording
Reason: Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Code information: Lot # 153855, exp 01/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications