Drug product
CANDESARTAN CILEXETIL, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00186001631.
D-882-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Tablets
- Official record key
drug-enforcement:D-882-2014
Official wording
Reason: Labeling: Label Mixup: CANDESARTAN CILEXETIL, Tablet, 16 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC 65862063830, Pedigree: W003649, EXP: 6/25/2014.
Code information: CANDESARTAN CILEXETIL, Tablet, 16 mg has the following codes: Pedigree: W003611, EXP: 6/25/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled