February 2017 FDA Recall Edex by Endo Pharmaceuticals, Inc.
D-0512-2017 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Endo Pharmaceuticals, Inc. on February 22, 2017 for the product Edex. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0512-2017
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
02-22-2017
03-15-2017
5,086 cartridges
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.
Endo Pharmaceuticals, Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
06-12-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02.
Batch or Lot Expiration Information
Lot# : 207386, Exp. May 2019
