Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Fl...
FDA Recall #D-1662-2012 — Class II — June 14, 2007
Product Description
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
Reason for Recall
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Recalling Firm
Apotex Corp. — Weston, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
31
Distribution
Nationwide.
Code Information
Lot #: GZ1274, Exp 11/07.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated