Anticoagulant recalled over life-threatening risk

Contamination in 22 lots of the injection may cause pulmonary embolism or vascular occlusion; no related adverse events reported.

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Par Health USA voluntarily recalled 22 lots of argatroban injection nationwide after detecting particulate contamination.
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The particles included cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel.
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The company warned that affected injections could cause pulmonary emboli, vascular occlusion with tissue or organ damage, and venous inflammation that may lead to clot formation.
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The recall covers 20 lots under NDC 42023-182-01 and 2 lots under NDC 42023-182-89, distributed to US wholesalers and hospitals from December 30, 2024, through May 5, 2026.
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Wholesale distributors and hospital pharmacies should immediately stop using and distributing affected lots, and notify downstream recipients if products were redistributed.

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