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TOPIC: 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.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a direct thrombin inhibitor indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention.
RECOMMENDATIONS:
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Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.
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Questions regarding this recall can be directed to the company at 1-855-648-7909 or by email at rxrecalls@inmar.com.
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For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393.
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