Edex — Class II drug recall D-0512-2017
Terminated recall by Endo Pharmaceuticals, Inc., reported 2017-03-15, distributed nationwide. Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
| Recall number | D-0512-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Endo Pharmaceuticals, Inc., Malvern, PA, United States |
| Recall initiated | 2017-02-22 |
| Classified | 2017-03-03 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2018-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 5,086 cartridges |
| Reason classes | sterility, packaging |
| NDC | 52244-0010, 52244-0010-02, 52244-0010-06, 52244-0020, 52244-0020-02, 52244-0020-06, 52244-0040, 52244-0040-02, 52244-0040-06 |
| Lot numbers | 207386 |
| Expiration dates | 2019-05-20 |
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 for recall
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0512-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.