FDA recall D-1029-2014

Aidapak Services, LLC · Class II · drug

Product

SELENIUM, Tablet, 50 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904316260.

Reason for recall

Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD56917_13, EXP: 5/21/2014.

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-1029-2014