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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 MELATONIN, Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 08770140813
Recall Number D-497-2014
Classification Class II
Code Info MELATONIN, Tablet, 3 mg has the following codes Pedigree: AD46257_56, EXP: 5/15/2014; Pedigree: W003022, EXP: 6/12/2014; Pedigree: W003723, EXP: 6/26/2014; Pedigree: AD21846_34, EXP: 5/1/2014; Pedigree: AD30028_28, EXP: 5/7/2014; Pedigree: AD60240_39, EXP: 5/22/2014; Pedigree: AD73521_31, EXP: 5/30/2014; Pedigree: W002701, EXP: 6/5/2014; Pedigree: W003320, EXP: 6/19/2014.
Product Distributed Qty 3,710 Tablets
Reason For Recall Labeling: Label Mixup; MELATONIN, Tablet, 3 mg may be potentially mislabeled as VITAMIN B COMPLEX, Capsule, NDC 00536478701, Pedigree: AD32757_4, EXP: 5/13/2014; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, NDC 24208063210, Pedigree: W003025, EXP: 6/12/2014; LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: W003721, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, NDC 00904548152, Pedigree: AD21846_14, EXP: 5/1/2014; OXcarbazepine, Tablet, 600 mg, NDC 62756018588, Pedigree: AD30140_46, EXP: 5/7/2014; LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD60240_36, EXP: 5/22/2014; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), NDC 00904506260, Pedigree: AD73521_28, EXP: 5/30/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W002691, EXP: 6/5/2014; OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003333, EXP: 6/19/2014.

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.