Leflunomide Tablet
FDA Recall NDC 60505-2502
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Leflunomide (NDC 60505-2502). A significant event, classified as Class II, was initiated on Jun 14, 2007 by Apotex Corp.. The reported reason for this action was: "Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Jun 14, 2007
Sep 05, 2012
3063
Recall Profile & Regulatory Data
Event ID
38329
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Aug 28, 2012
Product Description
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
Batch or Lot Expiration Information
Lot# : a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07.
Affected Packages Involved in this Recall
60505-2502-1Product
60505-2502-2Product
60505-2502-3Product
60505-2503-1Product
60505-2503-2Product
60505-2503-3Product
Class II Terminated
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Jun 14, 2007
Sep 05, 2012
31
Recall Profile & Regulatory Data
Event ID
38329
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Aug 28, 2012
Product Description
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
Batch or Lot Expiration Information
Lot# : GZ1274, Exp 11/07.
Affected Packages Involved in this Recall
60505-2502-1Product
60505-2502-2Product
60505-2502-3Product
60505-2503-1Product
60505-2503-2Product
60505-2503-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
