Drug recall D-0512-2017
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.
Reason for recall
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Lots and codes
Lot #: 207386, Exp. May 2019
Recall details
- Recalling firm
- Endo Pharmaceuticals, Inc., Malvern, PA
- Quantity
- 5,086 cartridges
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 22, 2017
- Terminated
- June 12, 2018
Related products
- Edex – drug information
- NDC 52244-020 Edex · Alprostadil 20 ug/mL · Endo USA, Inc.
- NDC 52244-040 Edex · Alprostadil 40 ug/mL · Endo USA, Inc.
- NDC 52244-010 Edex · Alprostadil 10 ug/mL · Endo USA, Inc.