Reported Nov 29, 2017 · Terminated

TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit…

United Therapeutics Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: United Therapeutics Corp. · 55 Tw Alexander Dr · Durham, NC · 27709-0152

Is this the product you have?

  • 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
Lot codes and dates
    • Lot #: 2101152
    • Exp. 12/11/2017 Lot #: 2101195
    • Exp. 04/26/2019
Amount recalled
12 devices

Where it was sold

Why it was recalled

CGMP Deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 3, 2019 · Data as of Sep 19, 6:32 PM UTC

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