United Therapeutics Corp.

FDA Regulatory Profile

United Therapeutics Corp. appears in FDA public data with 3 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1188-2018, Class III) was initiated on August 14, 2018.

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