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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 CINACALCET HCL Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007330
Recall Number D-624-2014
Classification Class II
Code Info CINACALCET HCL, Tablet, 30 mg has the following codes Pedigree: W003168, EXP: 6/13/2014; Pedigree: AD54516_4, EXP: 5/20/2014; Pedigree: AD32757_50, EXP: 5/14/2014; Pedigree: W003615, EXP: 6/25/2014; Pedigree: AD52778_82, EXP: 5/21/2014; Pedigree: AD73597_13, EXP: 5/31/2014; Pedigree: W003481, EXP: 6/20/2014; Pedigree: W003492, EXP: 6/20/2014.
Product Distributed Qty 600 Tablets
Reason For Recall Labeling:Label Mixup; CINACALCET HCL, Tablet, 30 mg may be potentially mislabeled as ACETAMINOPHEN, Chew Tablet, 80 mg, NDC 00536323307, Pedigree: W003113, EXP: 6/13/2014; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), NDC 00904759160, Pedigree: AD54553_1, EXP: 5/20/2014; OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: AD32757_40, EXP: 5/14/2014; COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: W003612, EXP: 6/25/2014; quiNIDine SULFATE, Tablet, 200 mg, NDC 00591543801, Pedigree: AD52778_79, EXP: 5/21/2014; LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: AD73597_10, EXP: 5/31/2014; EXEMESTANE, Tablet, 25 mg, NDC 00054008013, Pedigree: W003471, EXP: 6/20/2014; LURASIDONE HCL, Tablet, 120 mg, NDC 63402031230, Pedigree: W003487, 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.