Drug product
IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093746556.
D-849-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Tablets
- Official record key
drug-enforcement:D-849-2014
Official wording
Reason: Labeling: Label Mixup: IRBESARTAN, Tablet, 150 mg may have potentially been mislabeled as the following drug: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD32757_7, EXP: 5/13/2014.
Code information: IRBESARTAN, Tablet, 150 mg has the following codes: Pedigree: AD42592_7, EXP: 5/14/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled