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U.S. Department of Health and Human Services

Enforcement Report - Week of July 5, 2012

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Event Detail

Event ID 62004
Product Type Drugs
Status Ongoing
Recalling Firm Shionogi Inc.
City Alpharetta
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-08
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern PA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01 Lot number: 2021956, Exp; 01/2013 Class II Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point. 7230 bottles D-1398-2012
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