FDA recall D-698-2014

Aidapak Services, LLC · Class II · drug

Product

FEBUXOSTAT Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764091830

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.

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-22
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-698-2014