Blood thinner recalled due to contamination risk

 

This voluntary recall includes 22 different lots of Argatroban Injection, a direct thrombin inhibitor used for prophylaxis or to treat blood clots in adult patients with heparin-induced thrombocytopenia (HIT). It can also work as an anticoagulant in adult patients with or at risk of HIT who are undergoing percutaneous coronary intervention (PCI) procedures. 

According to new details shared by the U.S. Food and Drug Administration (FDA), the particulate matter in question has been identified as cellulose, polystyrene, polyethylene, terephthalate and stopper material. Some of it may also be stainless steel. The Argatroban Injection being recalled is delivered to a patient intravenously. If patients were treated with the contaminated drug, they would face a risk “life-threatening adverse health consequences, including pulmonary emboli, occlusions of other blood vessels and/or inflammation of the wall of veins, which may lead to clotting.

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Par Health, a St. Louis-based pharmaceutical company, is recalling certain lots of a blood thinner due to the presence of particulate matter. This voluntary recall includes 22 different lots of Argatroban Injection, a direct thrombin inhibitor used for prophylaxis or to treat blood clots in adult patients with heparin-induced thrombocytopenia (HIT).

Part Health did emphasize that there have been no reports of adverse events related to this issue. 

The drugs included in this recall were distributed by Par Pharmaceutical or Endo USA from December to May 2026. The lots are all set to expire as early as October 2026 and as late as September 2027. 

“ Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution,” according to the advisory shared by the FDA. “If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.”

Michael Walter
Michael Walter, Managing Editor

Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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