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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 ISOSORBIDE DINITRATE ER Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664060088
Recall Number D-631-2014
Classification Class II
Code Info ISOSORBIDE DINITRATE ER, Tablet, 40 mg has the following code Pedigree: AD23082_4, EXP: 5/3/2014.
Product Distributed Qty 100 Tablets
Reason For Recall Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.

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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