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
Reported: November 29, 2017 Initiated: September 11, 2017 #D-0083-2018
Product Description
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
Details
- Recalling Firm
- United Therapeutics Corp.
- Units Affected
- 12 devices
- Distribution
- PA
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by United Therapeutics Corp.. Units affected: 12 devices.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 29, 2017. Severity: Moderate. Recall number: D-0083-2018.
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