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Silicone Particles in Product Leads to Recall of Treprostinil


One lot of treprostinil injection is being recalled. Tresprostinil is a prostacyclin vasodilator used to treat patients with pulmonary arterial hypertension.

Par Pharmaceutical, part of Endo International, is recalling one lot of Treprostinil Injection 20 mg/20 mL. The product is being recalled because of the presence of silicone particulates in the product solution.

Treprostinil Injection is a prostacyclin vasodilator used to treat patients with pulmonary arterial hypertension and for patients who require transition from epoprostenol. The presence of silicone can result in local irritation or swelling at the injection site. If the silicone particulates reach the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain. To date, Par has not received any reports of adverse events related to the silicone particles.

The affected lot 57014 has an NDC number of 42023-206-01. It has an expiration date April 2024. The lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through Oct. 17, 2022.

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