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

Recall Number: D-1662-2012

Firm: Apotex Corp.

Classification: Class II

Status: Terminated

Report Date: 20120905

Initiation Date: 20070614

Termination Date: 20120828

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

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