United Therapeutics recalls
FDA enforcement reports naming United Therapeutics Corp. as the recalling firm.
- Recall reports
- 3
- Class I (serious)
- 0
- Most recent report
- Sep 19, 2018
- Sep 19, 2018Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation…Drug · United Therapeutics Corp.Defective Delivery System: Water ingress through the lower water cup sensor of the device.Class III
- Nov 29, 2017TYVASO (treprostinil) Inhalation Solution Treprostinil 1Drug · United Therapeutics Corp.CGMP DeviationsClass II
- Jul 16, 2014Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1Drug · United Therapeutics Corp.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 diffe…Class II