FDA recall D-640-2014

Aidapak Services, LLC · Class II · drug

Product

ARIPiprazole Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000913

Reason for recall

Labeling:Label Mixup; ARIPiprazole, Tablet, 15 mg may be potentially mislabeled as ATOMOXETINE HCL, Capsule, 40 mg, NDC 00002322930, Pedigree: AD21790_82, EXP: 5/1/2014; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, NDC 13668009190, Pedigree: AD25264_10, EXP: 5/3/2014.

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-640-2014