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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 SEVELAMER CARBONATE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468013001
Recall Number D-637-2014
Classification Class II
Code Info SEVELAMER CARBONATE, Tablet, 800 mg has the following codes Pedigree: AD39858_4, EXP: 5/15/2014; Pedigree: AD70629_16, EXP: 5/29/2014; Pedigree: W002778, EXP: 6/6/2014; Pedigree: W002859, EXP: 6/7/2014; Pedigree: W003029, EXP: 6/11/2014; Pedigree: AD56917_4, EXP: 5/21/2014; Pedigree: AD73627_11, EXP: 5/30/2014; Pedigree: W002710, EXP: 6/6/2014; Pedigree: W002623, EXP: 6/4/2014; Pedigree: W003491, EXP: 6/20/2014.
Product Distributed Qty 3,238 Tablets
Reason For Recall Labeling:Label Mixup; SEVELAMER CARBONATE Tablet, 800 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD46265_16, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD70629_13, EXP: 5/29/2014; QUEtiapine FUMARATE, Tablet, 100 mg, NDC 60505313301, Pedigree: W002777, EXP: 6/6/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W002851, EXP: 6/7/2014; DOCUSATE SODIUM, Capsule, 100 mg, NDC 57896040110, Pedigree: W002977, EXP: 6/11/2014; DILTIAZEM HCL ER, Capsule, 240 mg, NDC 49884083109, Pedigree: AD56917_1, EXP: 5/21/2014; MULTIVITAMIN/MULTIMINERAL LOW IRON, Tablet, NDC 64376081601, Pedigree: AD73627_8, EXP: 5/30/2014; MELATONIN, Tablet, 1 mg, NDC 35046000391, Pedigree: W002695, EXP: 6/5/2014; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, NDC 00904323392, Pedigree: W002610, EXP: 6/4/2014; CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003492, 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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