Multi event Drug Recall Enforcement Report Class II voluntary initiated by Apotex Corp., originally initiated on 06-14-2007 for the 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 The product was recalled due to subpotent (single ingredient drug): distribution of product that did not meet specifications.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1662-2012 | 06-14-2007 | 09-05-2012 | Class II | 31 | 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 | Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. | Terminated |
| D-1661-2012 | 06-14-2007 | 09-05-2012 | Class II | 3063 | 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 | Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 60505-2502 | Leflunomide | Leflunomide | Tablet | Oral | Apotex Corp. | Human Prescription Drug |
| 60505-2503 | Leflunomide | Leflunomide | Tablet | Oral | Apotex Corp. | Human Prescription Drug |
