Drug 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
D-0083-2018
Product summary
- Event
- Event 78170
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 devices
- Official record key
drug-enforcement:D-0083-2018
Official wording
Reason: CGMP Deviations
Code information: Lot #: 2101152; Exp. 12/11/2017 Lot #: 2101195; Exp. 04/26/2019
Distribution pattern: PA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations