Endo Pharmaceuticals, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 5 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0622-2024 | Class I | Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister card | July 10, 2024 |
| D-0475-2023 | Class II | Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 Internation | March 2, 2023 |
| D-0009-2019 | Class I | robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Ph | September 17, 2018 |
| D-0512-2017 | Class II | Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in German | February 22, 2017 |
| D-1381-2012 | Class III | Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx o | May 7, 2012 |