Edex Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 52244-040
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Edex (NDC 52244-040). A significant event, classified as Class II, was initiated on Feb 22, 2017 by Endo Usa, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks"
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
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Feb 22, 2017
Mar 15, 2017
5,086 cartridges
Recall Profile & Regulatory Data
Event ID
76542
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Endo Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jun 12, 2018
Product Description
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
Affected Packages Involved in this Recall
52244-010-01Product
52244-010-02Product
52244-010-06Product
52244-020-01Product
52244-020-02Product
52244-020-06Product
52244-040-01Product
52244-040-02Product
52244-040-06Product
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.
