Par Health initiates voluntary recall of Argatroban injection after detecting particulate contaminants

Par Health USA announced a voluntary nationwide recall of its Argatroban Injection 250 mg/2.5 mL product, affecting 22 lots that have been distributed to hospitals and users.

The recall was triggered after testing revealed particulate matter, including cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel, within the vials.

The presence of these particles could cause serious health risks such as pulmonary emboli, vascular occlusions, tissue damage, or vein inflammation, although the company reports no adverse events to date.

Par Health is working with the FDA to retrieve the affected lots and advises healthcare providers to stop using the product until it is returned.