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

Firm: Apotex Corp.

Classification: Class II

Status: Terminated

Report Date: 20120905

Initiation Date: 20070614

Termination Date: 20120828

Reason for Recall

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

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