TYVASO — Class II drug recall D-0083-2018
Terminated recall by United Therapeutics Corp., reported 2017-11-29, distributed in PA. CGMP Deviations
| Recall number | D-0083-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Therapeutics Corp., Durham, NC, United States |
| Recall initiated | 2017-09-11 |
| Classified | 2017-11-19 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2019-04-03 |
| Distributed | PA |
| Quantity | 12 devices |
| Reason classes | cgmp |
| Lot numbers | 2101152, 2101195 |
| Model numbers | TD-100/A |
| Expiration dates | 2017-12-11, 2019-04-26 |
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 for recall
CGMP Deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0083-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.