FDA recall D-856-2014

Aidapak Services, LLC · Class II · drug

Product

MEXILETINE HCL, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093874001.

Reason for recall

Labeling: Label Mixup: MEXILETINE HCL, Capsule, 200 mg may have potentially been mislabeled as the following drug: ISOSORBIDE DINITRATE, Tablet, 10 mg, NDC 00781155601, Pedigree: AD25264_1, EXP: 5/3/2014.

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-856-2014