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FDAFDA · Food and drugs·Recall number D-874-2014

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

Published January 29, 2014 · Recall initiated: July 2, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Telephone

Recall details

Manufacturer
Aidapak Services, LLC
Distributor
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Lot
OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg has the following codes: Pedigree: AD46265_43, EXP: 5/15/2014; Pedigree: W002736, EXP: 6/6/2014; Pedigree: W003243, EXP: 6/17/2014; Pedigree: W003692, EXP: 6/26/2014; Pedigree: AD32757_40, EXP: 5/14/2014; Pedigree: W003011, EXP: 6/12/2014; Pedigree: W003333, EXP: 6/19/2014.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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