Durham, NC, United States
United Therapeutics Corp. recalls
1 recall recorded since 2018, most recently on 14 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 14 August 2018
- Terminated
- 30 October 2019
- Reason
- Defective Delivery System: Water ingress through the lower water cup sensor of the device.
- Distribution
- IL, PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1188-2018
- 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 O
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.