Par Health is voluntarily recalling 22 lots of argatroban injection nationwide after particulate matter was detected in certain lots, warning that administration could cause life-threatening complications. The recall extends to hospitals and other users.
The affected product is argatroban injection 250 milligrams per 2.5 milliliters, at a concentration of 100 milligrams per milliliter. Identified particles include cellulose, polystyrene, polyethylene terephthalate, stopper material and possibly stainless steel.
Par Health said contaminated injections could cause pulmonary emboli, blockages in other blood vessels that lead to tissue death or organ damage, and inflammation of vein walls that may trigger clotting. The company has received no reports of adverse events associated with the recall.
Argatroban is a direct thrombin inhibitor used to prevent or treat thrombosis in adults with heparin-induced thrombocytopenia. It is also used as an anticoagulant during percutaneous coronary intervention in adults with, or at risk for, that condition.
The recalled lots carry National Drug Codes 42023-182-01 and 42023-182-89, with expiration dates ranging from October 2026 through September 2027. They were distributed to wholesalers and hospitals between Dec. 30, 2024, and May 5, 2026.
Labels identify Par Pharmaceutical or Endo USA as distributors. Both are predecessor companies to Par Health USA, the current distributor.
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