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U.S. Department of Health and Human Services

Enforcement Report - Week of February 18, 2015

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Product Detail

Product Description Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86
Recall Number D-0386-2015
Classification Class II
Code Info Lot #: JKN0249A Exp 02/2016
Product Distributed Qty 3263 bottles
Reason For Recall Failed Dissolution Specifications: Failure of dissolution test observed at the 6 month time point

Event Detail

Event Id 70339
Product Type Drugs
Status Ongoing
Recalling Firm Sun Pharma Global Fze
City Sharm
Country AE
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2015-01-21
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide.