FDAFDA · Food and drugs·Recall number D-0512-2017
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.
Published March 15, 2017 · Recall initiated: February 22, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- EDEX
- Manufacturer
- Endo Pharmaceuticals, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 207386, Exp. May 2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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