United Therapeutics Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
| D-1188-2018 | Class III | Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Tre | August 14, 2018 |
| D-0083-2018 | Class II | TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation | September 11, 2017 |
| D-1423-2014 | Class II | Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Ora | March 28, 2014 |