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 #: 2101152Exp. 12/11/2017 Lot #: 2101195Exp. 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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