Drug recall D-1661-2012

Class II Terminated reported Sep 5, 2012

Product

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

Reason for recall

Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

Lots and codes

Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07.

Recall details

Recalling firm
Apotex Corp., Weston, FL
Quantity
3063
Distribution
Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
June 14, 2007
Terminated
August 28, 2012

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