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.
Reported: March 15, 2017 Initiated: February 22, 2017 #D-0512-2017
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
Details
- Recalling Firm
- Endo Pharmaceuticals, Inc.
- Units Affected
- 5,086 cartridges
- Distribution
- Nationwide within the United States
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Endo Pharmaceuticals, Inc.. Units affected: 5,086 cartridges.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 15, 2017. Severity: Moderate. Recall number: D-0512-2017.
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