Why it was recalled
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Product description
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 numbers, UPCs & expiration codes
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
Where it was sold
IL, PA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1188-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 14, 2018
- FDA report date
- Sep 19, 2018
- Quantity
- 2801 devices
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- United Therapeutics Corp.
Original FDA data
Every field from FDA enforcement report D-1188-2018, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 80834
- Address
- 55 Tw Alexander Dr
- Code information
- 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
- Postal code
- 27709
- Report date
- Sep 19, 2018
- Product type
- Drugs
- Recall number
- D-1188-2018
- Classification
- Class III
- Recalling firm
- United Therapeutics Corp.
- Product quantity
- 2801 devices
- Termination date
- Oct 30, 2019
- Reason for recall
- Defective Delivery System: Water ingress through the lower water cup sensor of the device.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- IL, PA
- Recall initiation date
- Aug 14, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 12, 2018