# FDA recall D-1188-2018

> **United Therapeutics Corp.** · Class III · drug recall initiated 2018-08-14.

## 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

- **Recall number:** D-1188-2018
- **Recalling firm:** United Therapeutics Corp.
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-1188-2018. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-1188-2018. Source: US FDA. Licensed CC0.

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