Par Recalls 7 Treprostinil Lots

Endo’s Par Pharmaceutical is recalling seven lots of treprostinil injection 20g/20mL due to the potential for the presence of silicone particulates in the product solution. “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.” Currently, Par says it has not received any adverse event reports related to the issue.

Treprostinil injection is described as a prostacyclin vasodilator 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.