FDA recall D-848-2014

Aidapak Services, LLC · Class II · drug

Product

VENLAFAXINE HCL ER, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093738656.

Reason for recall

Labeling: Label Mixup: VENLAFAXINE HCL ER, Capsule, 150 mg may have potentially been mislabeled as one of the following drugs: SOTALOL HCL, Tablet, 80 mg, NDC 00093106101, Pedigree: AD30993_17, EXP: 5/9/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: W003075, EXP: 6/12/2014; LANTHANUM CARBONATE, CHEW Tablet, 500 mg, NDC 4092025290, Pedigree: W003410, 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-848-2014