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United Therapeutics Recalls
3 recalls on record · July 16, 2014 to September 19, 2018 · Drugs
Recalls by year
14
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 19, 2018DrugsFDA
United Therapeutics Corp. recalls Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.
Hazard: Defective Delivery System: Water ingress through the lower water cup sensor of the device.
November 29, 2017DrugsFDA
United Therapeutics Corp. recalls TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit M
Hazard: CGMP Deviations
July 16, 2014DrugsFDA
United Therapeutics Corp. recalls Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Onl
Hazard: Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.