United Therapeutics Corp. recalls Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.…
- Recall date
- August 14, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1188-2018
- FDA classification
- Class III
- Brand / firm
- United Therapeutics Corp.
- Sold / distributed
- IL, PA
Why it was recalled
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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