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
Recall Number: D-0083-2018
Firm: United Therapeutics Corp.
Classification: Class II
Status: Terminated
Report Date: 20171129
Initiation Date: 20170911
Termination Date: 20190403
Reason for Recall
CGMP Deviations
Product Description
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