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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 COENZYME Q-10, Capsule 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 37205055065
Recall Number D-549-2014
Classification Class II
Code Info COENZYME Q-10, Capsule, 100 mg has the following codes Pedigree: AD30180_16, EXP: 5/9/2014; Pedigree: AD32325_4, EXP: 5/9/2014; Pedigree: AD37056_4, EXP: 5/10/2014; Pedigree: AD70655_11, EXP: 5/28/2014; Pedigree: W002711, EXP: 6/6/2014; Pedigree: W003871, EXP: 6/27/2014; Pedigree: W003998, EXP: 7/1/2014; Pedigree: AD68019_4, EXP: 5/28/2014.
Product Distributed Qty 341 Capsules
Reason For Recall Labeling: Label Mixup; COENZYME Q-10 Capsule, 100 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD30180_13, EXP: 5/9/2014; ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: AD33897_1, EXP: 5/9/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD37056_1, EXP: 5/10/2014; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 57664050652, Pedigree: AD68010_17, EXP: 5/28/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002710, EXP: 6/6/2014; SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: W003866, EXP: 6/27/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: W003997, EXP: 7/1/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD68019_1, 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.