FDA recall D-833-2014

Aidapak Services, LLC · Class II · drug

Product

SOTALOL HCL, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106101.

Reason for recall

Labeling: Label Mixup: SOTALOL HCL, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: DILTIAZEM HCL, Tablet, 120 mg, NDC 00093032101, Pedigree: AD30197_1, EXP: 5/9/2014; PROPRANOLOL HCL ER, Capsule, 60 mg, NDC 00228277811, Pedigree: AD54605_4, EXP: 5/20/2014.

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-833-2014