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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921
Recall Number D-553-2014
Classification Class II
Code Info 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 Distributed Qty 36,840 Capsules
Reason For Recall 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, NDC 00536379001, Pedigree: W003712, EXP: 6/26/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W003715, EXP: 6/26/2014; CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg, NDC 00093029401, Pedigree: AD46426_28, EXP: 5/15/2014; SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: W002917, EXP: 6/10/2014; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, NDC 00904548152, Pedigree: W003316, EXP: 6/18/2014; MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD32325_7, EXP: 5/9/2014; BUMETANIDE, Tablet, 0.5 mg, NDC 00093423201, Pedigree: AD46426_25, EXP: 5/15/2014; COLESEVELAM HCL, Tablet, 625 mg, NDC 65597070118, Pedigree: AD46426_19, EXP: 5/15/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD60211_14, EXP: 5/22/2014; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, NDC 24208063210, Pedigree: AD73521_37, EXP: 5/30/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: W002701, EXP: 6/5/2014; BENZOCAINE/MENTHOL, LOZENGE, 15 mg/3.6 mg, NDC 63824072016, Pedigree: W003273, EXP: 6/17/2014.

Event Detail

Event Id 65707
Product Type Drugs
Status Ongoing
Recalling Firm Aidapak Services, LLC
City Vancouver
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-02
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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