Why it was recalled
CGMP Deviations
Product description
TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601
Lot numbers, UPCs & expiration codes
Lot #: 2101152; Exp. 12/11/2017 Lot #: 2101195; Exp. 04/26/2019
Where it was sold
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-0083-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 11, 2017
- FDA report date
- Nov 29, 2017
- Quantity
- 12 devices
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- United Therapeutics Corp.
Original FDA data
Every field from FDA enforcement report D-0083-2018, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 78170
- Address
- 55 Tw Alexander Dr
- Code information
- Lot #: 2101152; Exp. 12/11/2017 Lot #: 2101195; Exp. 04/26/2019
- Postal code
- 27709-0152
- Report date
- Nov 29, 2017
- Product type
- Drugs
- Recall number
- D-0083-2018
- Classification
- Class II
- Recalling firm
- United Therapeutics Corp.
- Product quantity
- 12 devices
- Termination date
- Apr 3, 2019
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601
- Distribution pattern
- PA
- Recall initiation date
- Sep 11, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 19, 2017