FDA recall D-0083-2018

United Therapeutics Corp. · Class II · 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

Reason for recall

CGMP Deviations

Distribution

PA

Key facts

Status
Terminated
Initiation date
2017-09-11
Report date
2017-11-29
Termination date
2019-04-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0083-2018