FDA-Drug2017-11-29Class II
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
United Therapeutics Corp.
Hazard
CGMP Deviations
Sold states
PA
Affected count
12 devices
Manufactured in
55 Tw Alexander Dr, N/A, Durham, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0083-2018Don't want to check this manually?
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