Recalls / Class II
Class IID-698-2014
Product
FEBUXOSTAT Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764091830
- Affected lot / code info
- 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.
Why it was recalled
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.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 300 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-698-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.