Omega-3-acid Ethyl Esters recall: Labeling Error
OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00173078302.
Why was Omega-3-acid Ethyl Esters 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00173078302.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 1439 Capsules
- Distribution
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)