FDAAugust 14, 2018drug
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
What to do
FDA enforcement status: Terminated
Brands named
united therapeuticsunited
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAFirst Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.2026-01-20
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