FDA recall D-834-2014

Aidapak Services, LLC · Class II · drug

Product

SOTALOL HCL, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106201.

Reason for recall

Labeling: Label Mixup: SOTALOL HCL, Tablet, 160 mg may have potentially been mislabeled as the following drug: DISULFIRAM, Tablet, 250 mg, NDC 64980017101, Pedigree: AD22609_1, EXP: 5/2/2014.

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-834-2014