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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, 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
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
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