CLASS II Drug recall · Reported 15 Mar 2017 · FDA Enforcement Report
Edex (alprostadil for injection) 10mcg recalled by Endo Pharmaceuticals
Endo Pharmaceuticals is recalling Edex (alprostadil for injection) 10mcg, distributed nationwide in the US. The recall was initiated on 22 Feb 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0512-2017
- FDA event ID
- 76542
- Recalling firm
- Endo Pharmaceuticals, Malvern, PA
- Brand
- Edex
- Manufacturer
- Endo USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Feb 2017
- FDA classified
- 3 Mar 2017
- Reported
- 15 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Feb 2017 | Recall initiated by company | |
| 3 Mar 2017 | Classified by FDA | +9 days |
| 15 Mar 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Which lots are affected?
Lot #: 207386, Exp. May 2019
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Endo Pharmaceuticals
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets recalledClonazepam | Endo Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS II | Calcitonin Salmon Nasal Spray recalled by Endo PharmaceuticalsCalcitonin Salmon | Endo Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | robaxin-750 (methocarbamol tablets, USP), 750 mg recalled | Endo Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg recalled | Endo Pharmaceuticals | Other | Nationwide |
Other Alprostadil recalls
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS III | Alprostadil Injection USP 500 mcg/mL Single Dose Vial, 5 vials recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Alprostadil 25mcg/ML 25mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Alprostadil 32mcg/ML 32mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Alprostadil 30mcg/ML Inj 30mcg/ML Injectable recalled by Vita Pharmacy | Vita Pharmacy | Sterility | DC, PR |