Recalls / Class II
Class IID-0083-2018
Product
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
- Affected lot / code info
- Lot #: 2101152; Exp. 12/11/2017 Lot #: 2101195; Exp. 04/26/2019
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- United Therapeutics Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Tw Alexander Dr, N/A, Durham, North Carolina 27709-0152
Distribution
- Quantity
- 12 devices
- Distribution pattern
- PA
Timeline
- Recall initiated
- 2017-09-11
- FDA classified
- 2017-11-19
- Posted by FDA
- 2017-11-29
- Terminated
- 2019-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0083-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.