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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 MONONITRATE, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175010701
Recall Number D-670-2014
Classification Class II
Code Info ISOSORBIDE MONONITRATE, Tablet, 20 mg has the following codes Pedigree: AD52778_31, EXP: 5/20/2014; Pedigree: AD67989_10, EXP: 5/28/2014; Pedigree: W002656, EXP: 6/4/2014.
Product Distributed Qty 300 Tablets
Reason For Recall Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 20 mg may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD52778_22, EXP: 5/20/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD67989_7, EXP: 5/28/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W002611, EXP: 6/4/2014.

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.