Drug product
Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3
D-1662-2012
Product summary
- Firm
- Apotex Corp.
- Event
- Event 38329
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31
- Official record key
drug-enforcement:D-1662-2012
Official wording
Reason: Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Code information: Lot #: GZ1274, Exp 11/07.
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent