Endo International plc, a company based in Dublin, Ireland, announced that its operating branch, Par Pharmaceutical, Inc., is recalling a specific batch of Treprostinil Injection 20mg/20mL (1mg/mL). The medicine is being recalled due to the possible presence of silicone particles in the product.
The recall, carried out in partnership with the U.S. Food and Drug Administration, applies specifically to Treprostinil Injection 20mg/20mL (1mg/mL) marked with Lot code 57014 and an expiration date of 04/2024. The medication, packaged in 20-mL multi-dose vials, is distributed as a sterile solution for injection.
The batch in question was distributed nationally to wholesalers and hospitals from June 16, 2022, through October 17, 2022. Treprostinil Injection is a prostacyclin vasodilator designed to treat pulmonary arterial hypertension and can be administered through subcutaneous or intravenous infusion.
The company cautioned that the injection of a product containing such particulates might lead to local irritation or inflammation due to the foreign substances. Furthermore, if these particles reach the bloodstream, they could travel to different organs, causing potentially life-threatening blockages in heart, lung, or brain vessels. To date, Par has not received any reports of adverse reactions linked to the recalled product.
Par is notifying wholesalers and hospitals that received the affected batch, and organizing for the return of all current inventory of Lot 57014 via Inmar, Inc. It has strongly urged all wholesale distributors and hospital pharmacies to immediately cease usage and distribution of the product.
Similar recalls include Hospira, Inc., a subsidiary of Pfizer Inc., which recalled certain Sodium Bicarbonate and Lidocaine HCL Injections last October due to potential glass particulates' presence. Additionally, Merck Animal Health, affiliated with Merck & Co., Inc., recalled three batches of Banamine/Banamine-S (flunixin meglumine injection) 50 mg/mL in the U.S. last year due to the detection of particulate matter.
