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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description 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
Recall Number D-1661-2012
Classification Class II
Code Info Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07.
Product Distributed Qty 3063
Reason For Recall Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

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.