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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 51991001406
Recall Number D-605-2014
Classification Class II
Code Info MELATONIN, Tablet, 3 mg has the following codes Pedigree: AD25452_16, EXP: 5/3/2014; Pedigree: AD28322_7, EXP: 5/6/2014; Pedigree: AD70655_14, EXP: 5/28/2014; Pedigree: W003999, EXP: 7/1/2014; Pedigree: AD32325_7, EXP: 5/9/2014; Pedigree: AD68019_7, EXP: 5/28/2014.
Product Distributed Qty 718 Tablets
Reason For Recall Labeling: Label Mixup; MELATONIN Tablet, 3 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD25452_13, EXP: 5/3/2014; PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD28322_4, EXP: 4/30/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD70655_11, EXP: 5/28/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W003998, EXP: 7/1/2014; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304062101, Pedigree: AD30140_1, EXP: 5/7/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD68019_4, EXP: 5/28/2014.

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.