Edex 10mcg recalled over sterility concerns
- Recall date
- February 22, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Endo Pharmaceuticals, Inc. recalls Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Phar…
- Recall number
- D-0512-2017
- FDA classification
- Class II
- Brand / firm
- Endo Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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.
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