FDA Drug recall D-1188-2018
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution
- FDA Drug
- Class III
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class III recall of Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution by United Therapeutics, citing defective Delivery System: Water ingress through the lower water cup sensor of the device.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1188-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-14 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | United Therapeutics |
| Distribution | IL, PA |
Product
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
Reason
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Identifiers
| ndc | 66302-206-01 |
|---|---|
| ndc | 66302-206-02 |
| ndc | 66302-206-03 |
| ndc | 66302-206-04 |
| code_info | Lot number a) 2101503, 2101507, 2101523, 2101532, 2101533, EXP 07/31/2019; 2101557, EXP 11/30/2019 b) Lot # 2101504, EX…Lot number a) 2101503, 2101507, 2101523, 2101532, 2101533, EXP 07/31/2019; 2101557, EXP 11/30/2019 b) Lot # 2101504, EXP 4/24/2021; 2101509, 2101522, EXP 5/8/2021; 2101531, EXP 5/15/2021; 2101534, EXP 6/10/2021; 2101543, EXP 6/14/2021; 2101558, EXP 7/26/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1188-2018%22
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