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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Detail

Product Description Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
Recall Number D-1702-2012
Classification Class II
Code Info Lot ZLMM12063, Exp March 2014
Product Distributed Qty 960 bottles
Reason For Recall Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.

Event Detail

Event Id 62885
Product Type Drugs
Status Completed
Recalling Firm Mylan Pharmaceuticals Inc.
City Morgantown
State WV
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern The product was distributed to KY.