Edex (alprostadil for injection) 10mcg recall: Sterility Concern
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.
Why was Edex (alprostadil for injection) 10mcg recalled?
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 207386, Exp. May 2019
- 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.
- Recalling firm
- Endo Pharmaceuticals, Inc.
- Quantity
- 5,086 cartridges
- Distribution
- Nationwide within the United States
- Recall date
- March 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)