Recall: D-1661-2012

Class II - Potentially Harmful

Class IIClassification

2007-06-14Initiated

TerminatedStatus

Apotex Corp.Firm

Product

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

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

Distribution

Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.