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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012
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Event Detail

Event ID 38329
Product Type Drugs
Status Terminated
Recalling Firm Apotex Corp.
City Weston
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-06-14
Initial Firm Notification of
Consignee or Public		 FAX
Distribution Pattern Nationwide.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9 Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07. Class II Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. 3063 D-1661-2012
Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3 Lot #: GZ1274, Exp 11/07. Class II Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. 31 D-1662-2012
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