Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 6050...
FDA Recall #D-1661-2012 — Class II — June 14, 2007
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
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
3063
Distribution
Nationwide.
Code Information
Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated