FDA Drug recall D-0512-2017
Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, La…
- FDA Drug
- Class II
- terminated
- Published 2017-03-15
On 2017-03-15 the FDA classified a Class II recall of Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, La… by Endo Pharmaceuticals, citing lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0512-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-22 |
| Published | 2017-03-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Endo Pharmaceuticals |
| Distribution | US |
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.
Reason
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Identifiers
| ndc | 52244-010-02 |
|---|---|
| ndc | 52244-010-06 |
| ndc | 52244-020-02 |
| ndc | 52244-020-06 |
| ndc | 52244-040-02 |
| ndc | 52244-040-06 |
| code_info | Lot #: 207386, Exp. May 2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0512-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.