FDA Drug Class II — Moderate

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.

Hazard

Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks

Products

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.
Brand
Endo Pharmaceuticals, Inc.
UPC
Lot #: 207386, Exp. May 2019

Units Affected

5,086 cartridges