Recalls / Class II
Class IID-0512-2017
Product
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.
- Brand name
- Edex
- Generic name
- Alprostadil
- Active ingredient
- Alprostadil
- Route
- Intracavernous
- NDCs
- 52244-010, 52244-020, 52244-040
- FDA application
- NDA020649
- Affected lot / code info
- Lot #: 207386, Exp. May 2019
Why it was recalled
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Recalling firm
- Firm
- Endo Pharmaceuticals, Inc.
- Manufacturer
- Endo USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1400 Atwater Drive, N/A, Malvern, Pennsylvania 19355
Distribution
- Quantity
- 5,086 cartridges
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2017-02-22
- FDA classified
- 2017-03-03
- Posted by FDA
- 2017-03-15
- Terminated
- 2018-06-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0512-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.