FDA recall D-513-2014

Aidapak Services, LLC · Class II · drug

Product

prednisoLONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC 16477050501

Reason for recall

Labeling: Label Mixup; prednisoLONE, Tablet, 5 mg may be potentially mislabeled as ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, NDC 00597000160, Pedigree: W003644, EXP: 8/24/2013.

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-513-2014