FDA recall D-966-2014

Aidapak Services, LLC · Class II · drug

Product

PROPAFENONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591058201.

Reason for recall

Labeling: Label Mixup: PROPAFENONE HCL, Tablet, 150 mg may have potentially been mislabeled as the following drug: FOSINOPRIL SODIUM, Tablet, 10 mg, NDC 00185004109, Pedigree: AD54549_7, 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-966-2014