PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 29, 2014 Initiated: July 2, 2013 #D-874-2014

Product Description

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

Details

Recalling Firm
Aidapak Services, LLC
Units Affected
1439 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location
Vancouver, WA

Frequently Asked Questions

What product was recalled?
OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00173078302.. Recalled by Aidapak Services, LLC. Units affected: 1439 Capsules.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Drug on January 29, 2014. Severity: Moderate. Recall number: D-874-2014.