United Therapeutics Corp. recalls TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit M
Recalled November 29, 2017 · FDA recall D-0083-2018 · United Therapeutics
Hazard
CGMP Deviations · FDA Class II
Units
12 devices
Sold at
PA
Description
CGMP Deviations
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
Manufacturer(s)
United Therapeutics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →