FDAFDA · Food and drugs·Recall number D-0083-2018
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
Published November 29, 2017 · Recall initiated: September 11, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- United Therapeutics Corp.
- Distributor
- PA
- Lot
- Lot #: 2101152; Exp. 12/11/2017 Lot #: 2101195; Exp. 04/26/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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