Par Pharmaceutical, an Endo International company, recalled one lot of treprostinil injection solutions because of the potential presence of silicone particles, the FDA said March 12.
The medication helps treat pulmonary arterial hypertension by diminishing symptoms linked to exercise. It is also used to reduce the rate of clinical deterioration among patients transitioning from epoprostenol.
The lot of the treprostinil injection 20 milligram per 20 milliliter solution was distributed to hospitals and wholesalers in summer 2022, according to the FDA.
A solution contaminated with a particulate matter can cause local irritation, swelling or blocked blood vessels in the heart, lungs or brain, which can lead to stroke or even death. No adverse events have been reported.