FDA recall D-994-2014

Aidapak Services, LLC · Class II · drug

Product

sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603580121.

Reason for recall

Labeling: Label Mixup: sulfaSALAzine, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: AD65475_16, EXP: 5/28/2014; PHENYTOIN SODIUM ER, Capsule, 30 mg, NDC 00071374066, Pedigree: W003331, EXP: 6/19/2014.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-29
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-994-2014