FDA-Drug2017-03-15Class II

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.

Endo Pharmaceuticals, Inc.
Hazard

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

Sold states
Nationwide within the United States
Affected count
5,086 cartridges
Manufactured in
1400 Atwater Drive, N/A, Malvern, PA, United States
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.

Official notice

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

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