Class I · High risk Ongoing
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only…
Reason Presence of Particulate Matter.
Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
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
- Recalling firm
- United Therapeutics Corp.
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1423-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Treprostinil recalls
See all
Class III · Low risk Terminated
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6…
Reason Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class II · Moderate risk Terminated
TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model#…
Reason CGMP Deviations
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