FDA recall D-859-2014

Aidapak Services, LLC · Class II · drug

Product

TERBUTALINE SULFATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115261101.

Reason for recall

Labeling: Label Mixup: TERBUTALINE SULFATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: SOTALOL HCL, Tablet, 80 mg, NDC 00093106101, Pedigree: AD52778_85, 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-859-2014