Drug product
BUMETANIDE, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093423301.
D-838-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-838-2014
Official wording
Reason: Labeling: Label Mixup: BUMETANIDE, Tablet, 1 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: W003218, EXP: 6/17/2014.
Code information: BUMETANIDE, Tablet, 1 mg has the following codes: Pedigree: W003224, EXP: 6/17/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled