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U.S. Department of Health and Human Services

Enforcement Report - Week of January 28, 2015

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Product Detail

Product Description LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
Recall Number D-0378-2015
Classification Class II
Code Info Lot Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;
Product Distributed Qty 3,993 cartons
Reason For Recall CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Event Detail

Event Id 66607
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 2013-09-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico.