CLASS II Drug recall · Reported 29 Nov 2017 · FDA Enforcement Report
Tyvaso (treprostinil) Inhalation Solution Treprostinil recalled
United Therapeutics is recalling Tyvaso (treprostinil) Inhalation Solution Treprostinil 1.74 mg/ (0.6 mg/mL) Tyvaso, distributed in Pennsylvania. The recall was initiated on 11 Sep 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0083-2018
- FDA event ID
- 78170
- Recalling firm
- United Therapeutics, Durham, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Sep 2017
- FDA classified
- 19 Nov 2017
- Reported
- 29 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 11 Sep 2017 | Recall initiated by company | |
| 19 Nov 2017 | Classified by FDA | +69 days |
| 29 Nov 2017 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
PA
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #: 2101152; Exp. 12/11/2017 Lot #: 2101195; Exp. 04/26/2019
Where was it sold?
PA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from United Therapeutics
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tyvaso Inhalation System Patient a) Starter Kit with Tyvaso recalledTyvaso | United Therapeutics | Other | IL, PA |
| Drug | CLASS II | Tyvaso (treprostinil) Inhalation Solution recalled | United Therapeutics | Other | TX |