FDA Drug recall D-1423-2014

Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for…

FDA Drug
Class II
terminated
Published 2014-07-16

On 2014-07-16 the FDA classified a Class II recall of Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for… by United Therapeutics, citing defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devic….

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1423-2014
Classification	Class II
Status	terminated
Initiated	2014-03-28
Published	2014-07-16
Last updated	2026-09-13 11:51 UTC
Company	United Therapeutics
Distribution	TX

Product

Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709

Reason

Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use.

Identifiers

code_info	Lot #s: TD-100: PCBA Lot 60 TD-100: PCBA Lot 61 TD-100: PCBA Lot 62 TD-100: PCBA Lot 63 Optineb: PCBA Lot 72 Opt… Lot #s: TD-100: PCBA Lot 60 TD-100: PCBA Lot 61 TD-100: PCBA Lot 62 TD-100: PCBA Lot 63 Optineb: PCBA Lot 72 Optineb: PCBA Lot 73 SERIAL NUMBERS: Kit S/N ML 1897 ML 1898 ML 1894 ML 1895 ML 1896 TD-100 S/N's 23103954 23103976 23104015 23104017 23104006 23104000 23103995 23104018 23104016 Optineb devices shipped to Caremark: Kit S/N ML 3660 MP 3662 ML 3665 MP 3667 MP 3668 MP 3676 MP 3683 MP 3690 ML 3691 MP 3692 Optineb S/N's 20900207 20900212 20900219 20900222 20900226 20900209 20900213 20900225 20900227 20900241 20900310 20900295 20900293 20900291 20900240 20900308 20900294 20900292 20900290 Kit S/N 3697 MP 3698 ML 3699 MP 3700 MP 3708 MP Optineb S/N's 20900262 20900283 20900285 20900265 20900253 20900264 20900284 20900286 20900268 20900315 NPR Device Not Part of Recall MP=Mount Prospect; ML-Monroeville TD-100 devices shipped to Accredo: Kit S/N 1879 1880 1881 1882 1883 1884 1885 1886 1887

code_info

Lot #s: TD-100: PCBA Lot 60 TD-100: PCBA Lot 61 TD-100: PCBA Lot 62 TD-100: PCBA Lot 63 Optineb: PCBA Lot 72 Opt…

Lot #s: TD-100: PCBA Lot 60 TD-100: PCBA Lot 61 TD-100: PCBA Lot 62 TD-100: PCBA Lot 63 Optineb: PCBA Lot 72 Optineb: PCBA Lot 73 SERIAL NUMBERS: Kit S/N ML 1897 ML 1898 ML 1894 ML 1895 ML 1896 TD-100 S/N's 23103954 23103976 23104015 23104017 23104006 23104000 23103995 23104018 23104016 Optineb devices shipped to Caremark: Kit S/N ML 3660 MP 3662 ML 3665 MP 3667 MP 3668 MP 3676 MP 3683 MP 3690 ML 3691 MP 3692 Optineb S/N's 20900207 20900212 20900219 20900222 20900226 20900209 20900213 20900225 20900227 20900241 20900310 20900295 20900293 20900291 20900240 20900308 20900294 20900292 20900290 Kit S/N 3697 MP 3698 ML 3699 MP 3700 MP 3708 MP Optineb S/N's 20900262 20900283 20900285 20900265 20900253 20900264 20900284 20900286 20900268 20900315 NPR Device Not Part of Recall MP=Mount Prospect; ML-Monroeville TD-100 devices shipped to Accredo: Kit S/N 1879 1880 1881 1882 1883 1884 1885 1886 1887

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1423-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.