Par Recalls More Treprostinil Due to Silicone in the Product


An additional seven lots of Treprostinil are affected on top of last month’s recall of one lot.

Par Pharmaceutical, a part of Endo International, is expanding its recall to include seven additional lots of Treprostinil Injection 20mg/20mL. The product is being recalled because of the possibility of silicone particulates in the product, the company said in a news release.

Treprostinil Injection is a prostacyclin vasodilator used to treat patients with pulmonary arterial hypertension and for patients who require transition from epoprostenol. The presence of silicone can result in local irritation or swelling at the injection site. If the silicone particulates reach the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain.

Treprostinil Injection is distributed in multidose vials as sterile solutions in water for injection with individually packaged in cartons with the NDC #42023-206-01. The lots were distributed nationwide to wholesalers and hospitals from June 16, 2022, through Aug. 7, 2023. The lots affected by this recall can be found here.

Related: Silicone Particles in Product Leads to Recall of Treprostinil

Last month, Par had recalled one lot of Treprostinil Injection for the same reason.

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