Par Pharmaceutical Recalls 1 Treprostinil Lot

Par Pharmaceutical is recalling one lot of treprostinil injection 20mg/20mL (1mg/mL) due to the potential for the presence of silicone particulates in the product solution. The prostacyclin vasodilator is indicated for treating pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require transition from epoprostenol to reduce the rate of clinical deterioration.

“Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material,” a recall notice says. “If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death.” To date, the company says it has not received any adverse event reports related to the matter.