Drug 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
D-1661-2012
Product summary
- Firm
- Apotex Corp.
- Event
- Event 38329
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3063
- Official record key
drug-enforcement:D-1661-2012
Official wording
Reason: Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Code information: Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07.
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent