Status
Terminated
Drug Enforcement D-698-2014
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.
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- FEBUXOSTAT Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764091830
- Product quantity
- 300 Tablets
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location & Firm
- Recalling firm
- Aidapak Services, LLC
- Address
-
14301 Se 1st St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-698-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- 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.
- More code info
- —