Drug 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.
D-0512-2017
Product summary
- Event
- Event 76542
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,086 cartridges
- Official record key
drug-enforcement:D-0512-2017
Official wording
Reason: Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Code information: Lot #: 207386, Exp. May 2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility