Drug product
BUMETANIDE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093423201.
D-837-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-837-2014
Official wording
Reason: Labeling: Label Mixup: BUMETANIDE, Tablet, 0.5 mg, Rx only may have potentially been mislabeled as the following drug: ERYTHROMYCIN DR EC, Tablet, 250 mg, NDC 24338012213, Pedigree: AD46426_13, EXP: 5/15/2014.
Code information: BUMETANIDE, Tablet, 0.5 mg, Rx only has the following codes: Pedigree: AD46426_25, EXP: 5/15/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled