Drug recall
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil…
FDA recall event 80834 · Class III · United Therapeutics Corp.
Key facts
| Event ID | 80834 |
|---|---|
| Recall numbers | D-1188-2018 |
| Recalling firm | United Therapeutics Corp. |
| Product type | Drugs |
| Products | Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defective Delivery System: Water ingress through the lower water cup sensor of the device. |
| Initiation date | Aug 14, 2018 |
| Report date | Sep 19, 2018 |
| Termination date | Oct 30, 2019 |
| City | Durham |
| State | NC |
| Country | United States |
| FEI number | 3003825766 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: