Class II · Moderate risk Ongoing
Alprostadil Container Description: Amber color bottle
Reason CGMP Deviations
Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
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.
- Recalling firm
- Endo Pharmaceuticals, Inc.
- NDC code
- 52244-010-02
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0512-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Alprostadil recalls
See all
Class III · Low risk Terminated
Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed…
Reason Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class II · Moderate risk Completed
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL…
Reason Lack of assurance of sterility.
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