FDA recall D-874-2014

Aidapak Services, LLC · Class II · drug

Product

OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00173078302.

Reason for recall

Labeling: Label Mixup: OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg may have potentially been mislabeled as one of the following drugs: SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD39858_4, EXP: 5/15/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W002735, EXP: 6/6/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W003229, EXP: 6/17/2014

Distribution

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

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-29
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-874-2014