D-0512-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 15, 2017
- Initiation Date
- February 22, 2017
- Termination Date
- June 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,086 cartridges
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.
Reason for Recall
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 207386, Exp. May 2019