# FDA recall D-1423-2014

> **United Therapeutics Corp.** · Class II · drug recall initiated 2014-03-28.

## 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 for recall

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.

## Distribution

Fl, TX.

## Key facts

- **Recall number:** D-1423-2014
- **Recalling firm:** United Therapeutics Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-03-28
- **Report date:** 2014-07-16
- **Termination date:** 2014-10-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Research Triangle Park, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1423-2014

## Citation

> AI Analytics. FDA recall D-1423-2014. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1423-2014. Source: US FDA. Licensed CC0.

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