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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 00904404360
Recall Number D-465-2014
Classification Class II
Code Info OMEGA-3 FATTY ACID, Capsule, 1000 mg has the following codes: Pedigree: AD33897_19, EXP: 5/9/2014; Pedigree: AD32328_5, EXP: 5/9/2014; Pedigree: W002852, EXP: 6/7/2014; Pedigree: AD62865_13, EXP: 5/23/2014; Pedigree: W002509, EXP: 6/3/2014; Pedigree: W003705, EXP: 6/25/2014; Pedigree: AD22845_7, EXP: 5/2/2014; Pedigree: AD39588_7, EXP:5/13/2014; Pedigree: AD73627_20, EXP: 5/30/2014; Pedigree: W003870, EXP: 6/27/2014; Pedigree: AD46300_14, EXP: 5/15/2014; Pedigree: AD60211_14, EXP: 5/22/2014; Pedigree: W003052, EXP: 6/12/2014; Pedigree: W003217, EXP: 6/14/2014; Pedigree: AD73623_4, EXP: 5/30/2014; Pedigree: W003462, EXP: 6/20/2014; Pedigree: W003195, EXP: 6/13/2014; Pedigree: W003473, EXP: 6/20/2014.
Product Distributed Qty 2,799 Capsules
Reason For Recall Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD33897_16, EXP: 5/9/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD33897_19, EXP: 5/9/2014; PSEUDOEPHEDRINE HCL, Tablet, 60 mg, NDC 00904512559, Pedigree: W002856, EXP: 6/7/2014; DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD62865_10, EXP: 5/23/2014; PHENobarbital, Tablet, 97.2 mg, NDC 00603516821, Pedigree: AD73518_10, EXP: 5/31/2014; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium), NDC 00904506260, Pedigree: W003720, EXP: 6/26/2014; DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD22609_4, EXP: 4/30/2014; ISOSORBIDE DINITRATE, Tablet, 10 mg, NDC 00781155601, Pedigree: AD32757_34, EXP: 5/14/2014; HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 00228282011, Pedigree: AD73652_7, EXP: 5/29/2014; LACTOBACILLUS GG, Capsule, 15 Billion Cells, NDC 49100036374, Pedigree: W003869, EXP: 6/27/2014; MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: AD46257_10, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet, 5000 units, NDC 00761017840, Pedigree: AD56917_10, EXP: 5/21/2014; ACETAMINOPHEN, Chew Tablet, 80 mg, NDC 00536323307, Pedigree: W003050, EXP: 6/12/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W003242, EXP: 6/17/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD73627_20, EXP: 5/30/2014; CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, NDC 00536342408, Pedigree: W003461, EXP: 6/20/2014; chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree: W003194, EXP: 6/13/2014; NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: W003463, EXP: 6/20/2014.

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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