Recalls / Class III
Class IIID-1188-2018
Product
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
- Brand name
- Tyvaso
- Generic name
- Treprostinil
- Active ingredient
- Treprostinil
- Route
- Oral
- NDC
- 66302-206
- FDA application
- NDA022387
- Affected lot / code info
- Lot number a) 2101503, 2101507, 2101523, 2101532, 2101533, EXP 07/31/2019; 2101557, EXP 11/30/2019 b) Lot # 2101504, EXP 4/24/2021; 2101509, 2101522, EXP 5/8/2021; 2101531, EXP 5/15/2021; 2101534, EXP 6/10/2021; 2101543, EXP 6/14/2021; 2101558, EXP 7/26/2021
Why it was recalled
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Recalling firm
- Firm
- United Therapeutics Corp.
- Manufacturer
- United Therapeutics Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Tw Alexander Dr, N/A, Durham, North Carolina 27709
Distribution
- Quantity
- 2801 devices
- Distribution pattern
- IL, PA
Timeline
- Recall initiated
- 2018-08-14
- FDA classified
- 2018-09-12
- Posted by FDA
- 2018-09-19
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1188-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.