Recalls / Class II
Class IID-1661-2012
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
- Brand name
- Leflunomide
- Generic name
- Leflunomide
- Active ingredient
- Leflunomide
- Route
- Oral
- NDCs
- 60505-2502, 60505-2503
- FDA application
- ANDA077090
- Affected lot / code info
- Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07.
Why it was recalled
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- FAX
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy, Ste 400, Weston, Florida 33326-3253
Distribution
- Quantity
- 3063
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2007-06-14
- FDA classified
- 2012-08-27
- Posted by FDA
- 2012-09-05
- Terminated
- 2012-08-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1661-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.