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