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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 LUBIPROSTONE Capsule, 24 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764024060
Recall Number D-697-2014
Classification Class II
Code Info LUBIPROSTONE Capsule, 24 mcg has the following codes Pedigree: AD21790_46, EXP: 5/1/2014; Pedigree: AD21811_1, EXP: 5/1/2014; Pedigree: AD46312_1, EXP: 5/16/2014.
Product Distributed Qty 180 Capsules
Reason For Recall Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD21790_43, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD21846_46, EXP: 5/1/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD39858_1, EXP: 5/16/2014.

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.