FDAFDA · Food and drugs·Recall number D-1661-2012
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
Published September 5, 2012 · Recall initiated: June 14, 2007
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
What to do
Voluntary: Firm initiated · FAX
Recall details
- Brand
- LEFLUNOMIDE
- Manufacturer
- Apotex Corp.
- Distributor
- Nationwide.
- Lot
- Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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