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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
Recall Number D-1155-2014
Classification Class III
Code Info Lots and Expiration Dates: 3037463, Expires 2/2014; 3039466, Expires 3/2014; 3040644, Expires 4/2014; 3043463, Expires 6/2014; 3049568, Expires 3/2015
Product Distributed Qty 3,252 cartons
Reason For Recall Failed Impurity/degradation Specification

Event Detail

Event Id 67393
Product Type Drugs
Status Ongoing
Recalling Firm Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
City Rockford
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US: Nationwide
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