Argatroban Injection by Par Health: Recall – Due to the Presence of Particulate Matter
AUDIENCE: Patient, Health Care Professional, Risk Manager, Pharmacy, Cardiology, Hematology, Pulmonology
ISSUE: Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level due to the presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel, that was detected in certain lots.
Administration of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting.
The lots were distributed nationwide to wholesalers and hospitals between December 30, 2024, and May 5, 2026.
To date, Par Health has not received any reports of adverse events related to this recall.