FDA recall D-1188-2018

Product

Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709

Reason for recall

Defective Delivery System: Water ingress through the lower water cup sensor of the device.

Distribution

IL, PA

Key facts

Status

Terminated

Initiation date

2018-08-14

Report date

2018-09-19

Termination date

2019-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1188-2018