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.
Is Treprostinil recalled?
4 FDA recalls mention Treprostinil. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Treprostinil.
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
Class II · Moderate risk Terminated
Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only…
Reason Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and…
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