Food, drugs, devices › United Therapeutics Corp.
Drug recall: Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9
United Therapeutics Corp. (Durham, NC) initiated this drug recall on 14 Aug 2018; FDA lists 1 product record under event 80834, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 30 Oct 2019. Initiation: voluntary: firm initiated. United Therapeutics Corp. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
United Therapeutics Corp., Durham, NC.
Reason for recall
"Defective Delivery System: Water ingress through the lower water cup sensor of the device."
Distribution
"IL, PA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1188-2018 | 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 Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709 | 2801 devices | Class III | Terminated | 19 Sep 2018 |
Context
Other enforcement events for United Therapeutics Corp.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Sep 2017 | TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit M | Drug | Class II | 1 |
| 28 Mar 2014 | Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Onl | Drug | Class II | 1 |
All 3 events for United Therapeutics Corp.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Defective Delivery System: Water ingress through the lower water cup sensor of the device."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "IL, PA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Oct 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.