Reported Sep 19, 2018 · Terminated
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74…
United Therapeutics Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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
Is this the product you have?
- Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709
- Lot codes and dates
Lot number a) 21015032101507210152321015322101533EXP 07/31/20192101557EXP 11/30/2019 b) Lot # 2101504EXP 4/24/202121015092101522EXP 5/8/20212101531EXP 5/15/20212101534EXP 6/10/20212101543EXP 6/14/20212101558EXP 7/26/2021
- Amount recalled
- 2801 devices
Where it was sold
Why it was recalled
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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