FDA recall D-613-2014

Aidapak Services, LLC · Class II · drug

Product

MESALAMINE CR Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092018981

Reason for recall

Labeling: Label Mixup; MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD52378_1, EXP: 5/17/2014.

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-22
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-613-2014