Class I Recall for Injection

Par Sterile Products is recalling 466 vials of treprostinil injection because the solution may contain silicone particulates. The recall, which appeared in the April 3, 2024, US Food and Drug Administration (FDA) Enforcement Report, was designated Class I. The classification is the FDA’s most significant and warns use of the affected solution could cause serious adverse health consequences or death.

“Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. 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,” Par Pharmaceutical announced in a March 12, 2024, statement. “To date, Par has not received any reports of adverse events related to this recall.”

The recall affects treprostinil injection, 20 mg/20 mL (1 mg/mL), 20-mL multiple-dose vials (NDC 42023-206-01), from lot 57014 (Exp. 4/30/24). The injection was distributed throughout the United States between June 16, 2022, and October 17, 2022, by Par Pharmaceutical, Chestnut Ridge, New York.

Par Sterile Products voluntarily initiated the recall on March 4, 2024. The FDA issued its Class I designation on March 28, 2024. Treprostinil injection is a prescription prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require transition from epoprostenol to reduce the rate of clinical deterioration. The injection is formulated for subcutaneous or intravenous infusion.