Multi-event June 2007 FDA Recall Leflunomide by Apotex Corp.
This Multi-event Class II drug recall was voluntarily initiated by Apotex Corp. on June 14, 2007 for the product Leflunomide. The FDA reported the reason for recall as subpotent (single ingredient drug). The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1661-2012
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
06-14-2007
09-05-2012
3063
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Apotex Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
08-28-2012
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07.
Affected Packages Involved in this Recall
Recall Number: D-1662-2012
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
06-14-2007
09-05-2012
31
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Apotex Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
08-28-2012
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# : GZ1274, Exp 11/07.
