United Therapeutics Corp.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1188-2018Class IIITyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. TreAugust 14, 2018
D-0083-2018Class IITYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation September 11, 2017
D-1423-2014Class IITyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For OraMarch 28, 2014