Drug product
FEBUXOSTAT Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764091830
D-698-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 Tablets
- Official record key
drug-enforcement:D-698-2014
Official wording
Reason: Labeling: Label Mixup; FEBUXOSTAT Tablet, 40 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 59746000103, Pedigree: AD21811_17, EXP: 5/1/2014; tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: W002663, EXP: 6/5/2014; SODIUM CHLORIDE, Tablet, 1000 mg, NDC 00527111610, Pedigree: W003926, EXP: 7/1/2014.
Code information: FEBUXOSTAT Tablet, 40 mg has the following codes Pedigree: AD23082_16, EXP: 11/1/2013; Pedigree: W002664, EXP: 6/5/2014; Pedigree: W003927, EXP: 7/1/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled