FDA Drug recall D-0083-2018
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
- terminated
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of 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… by United Therapeutics, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0083-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-11 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | United Therapeutics |
| Distribution | PA |
Product
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 Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601
Reason
CGMP Deviations
Identifiers
| code_info | Lot #: 2101152; Exp. 12/11/2017 Lot #: 2101195; Exp. 04/26/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0083-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.