Par Pharmaceutical recall Treprostinil Injection for Particulates

Dublin based Par Pharmaceutical, part of Endo International plc is recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) in US. The recall is due to potential presence of silicone particulates in the product solution.

Particulates in injectable products can cause local irritation or swelling and in extreme cases of the particulate reaching blood vessels can block vessels with potential to cause stroke and even death. However Parr has not received any adverse events so far.

Treprostinil is formulated for subcutaneous or intravenous infusion indicated for treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise

Recall Announcement