FDA 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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2017-02-22

Report date

2017-03-15

Termination date

2018-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0512-2017