Why it was recalled
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
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.
Lot numbers, UPCs & expiration codes
Lot #: 207386, Exp. May 2019
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0512-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 22, 2017
- FDA report date
- Mar 15, 2017
- Quantity
- 5,086 cartridges
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Endo Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0512-2017, exactly as published.
Show all FDA fields
- City
- Malvern
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 76542
- Address
- 1400 Atwater Drive
- Code information
- Lot #: 207386, Exp. May 2019
- Postal code
- 19355
- Report date
- Mar 15, 2017
- Product type
- Drugs
- Recall number
- D-0512-2017
- Classification
- Class II
- Recalling firm
- Endo Pharmaceuticals, Inc.
- Product quantity
- 5,086 cartridges
- Termination date
- Jun 12, 2018
- Reason for recall
- Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2017