FDA recall D-767-2014

Aidapak Services, LLC · Class II · drug

Product

ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323830.

Reason for recall

Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 18 mg, may be potentially mis-labeled as the following drug: LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: AD28369_1, EXP: 5/7/2014.

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-767-2014