# FDA recall D-0083-2018

> **United Therapeutics Corp.** · Class II · drug recall initiated 2017-09-11.

## 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

- **Recall number:** D-0083-2018
- **Recalling firm:** United Therapeutics Corp.
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0083-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0083-2018. Source: US FDA. Licensed CC0.

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