FDAClass IIJanuary 22, 2014

Omega-3 Fatty Acid Capsule recall: Labeling Error

OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921

Why was Omega-3 Fatty Acid Capsule recalled?

Labeling: Label Mixup; OMEGA-3 FATTY ACID Capsule, 1000 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD22865_19, EXP: 5/2/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD30028_7, EXP: 5/8/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W003054, EXP: 6/12/2014; CHOLECALCIFEROL, Capsule, 2000 units, ND

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 FATTY ACID Capsule, 1000 mg has the following codes Pedigree: AD21846_1, EXP: 5/1/2014; Pedigree: AD30028_4, EXP: 5/8/2014; Pedigree: W003015, EXP: 6/12/2014; Pedigree: W003710, EXP: 6/26/2014; Pedigree: W003711, EXP: 6/26/2014; Pedigree: AD46257_1, EXP: 5/15/2014; Pedigree: W002965, EXP: 6/10/2014; Pedigree: W003312, EXP: 6/18/2014; Pedigree: AD30028_1, EXP: 5/8/2014; Pedigree: AD46257_4, EXP: 5/15/2014; Pedigree: AD32742_1, EXP: 5/1/2014; Pedigree: AD60240_1, EXP: 5/22/2014; Pedigree: ADWA00002135, EXP: 5/31/2014; Pedigree: W002690, EXP: 6/5/2014; Pedigree: W003313, EXP: 6/18/2014.

Product
OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921
Recalling firm
Aidapak Services, LLC
Quantity
36,840 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls