U.S.-based generic drugmaker Par Health has issued a voluntary recall of 22 lots of the direct thrombin inhibitor argatroban for IV injection that could be contaminated with cellulose, polystyrene, polyethylene terephthalate, stopper material, and potentially even stainless steel.
The recall, which was published to the FDA’s website on Oct. 14th, is Par’s third in a matter of weeks.
On September 18th, the St. Louis-headquartered pharma recalled 2 lots of the IV sedative dexmedetomidine HCl in 0.9% sodium chloride injection over the risk of cellulose contamination. And last week on Oct. 8th, it reported the recall of another two lots of the IV barbiturate Brevital sodium that could be tainted with cellulose, as well as stopper material.
Par is among several drugmakers this year that have repeatedly struggled to get particulate contamination of their infused drugs under control.
The latest recall affects a substantial 22-lot supply of Par's argatroban injection 250 mg/2.5 mL (100 mg/mL), which was shipped to wholesalers and hospitals between December 30, 2024, and May 5, 2026. Some of the lots impacted by the recall are set to expire this month, October 2026.
Argatroban injection is used to treat or prevent blood clots in patients with heparin-induced thrombocytopenia (HIT).
To date, Par Health has not been informed of any adverse events related to the recall. But particulate-contaminated drug injections have the potential to be life threatening, capable of causing pulmonary emboli, occlusions of other blood vessels or inflammation of the walls of veins.
All wholesalers and hospital pharmacies that have the recalled product in stock should discontinue use immediately, according to the company announcement published by the FDA. Par health is partnering with healthcare logistics company Inmar to retrieve the affected lots.