United Therapeutics recalls
United Therapeutics appears in 3 official U.S. recall notices indexed by RecallRadar, most recently on 2018-09-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 3 |
|---|---|
| Published | 2014-07-16 to 2018-09-19 |
| By agency | FDA Drug (3) |
| By classification | Class II (2), Class III (1) |
| By status | terminated (3) |
| Distribution named in notices | IL, PA, TX |
Recalls
- Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution
FDA Drug · Class III · 2018-09-19 · United Therapeutics
Reason: Defective Delivery System: Water ingress through the lower water cup sensor of the device. - TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx…
FDA Drug · Class II · 2017-11-29 · United Therapeutics
Reason: CGMP Deviations - Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for…
FDA Drug · Class II · 2014-07-16 · United Therapeutics
Reason: 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…