Drug product
NABUMETONE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185014501.
D-880-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-880-2014
Official wording
Reason: Labeling: Label Mixup: NABUMETONE, Tablet, 500 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD46429_1, EXP: 5/15/2014.
Code information: NABUMETONE, Tablet, 500 mg has the following codes: Pedigree: AD46426_4, EXP: 5/15/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled