Par Health Recalls 22 Lots of Argatroban Injection for Particulate Matter. Ask Pharmacy Which Lots You Have.
The Oct. 13 recall covers argatroban 250 mg/2.5 mL vials shipped nationwide from Dec. 30, 2024, to May 5, 2026. Par reports no adverse events so far but warns of a risk of pulmonary emboli.
Par Health is recalling 22 lots of argatroban injection 250 mg/2.5 mL (100 mg/mL) to the hospital and user level because of particulate matter found in certain lots. The company announced the recall on Oct. 13, and the Food and Drug Administration posted the announcement on Oct. 14.
Argatroban is a direct thrombin inhibitor indicated for prophylaxis or treatment of thrombosis in adults with heparin-induced thrombocytopenia (HIT), and as an anticoagulant in adults with or at risk for HIT who are undergoing percutaneous coronary intervention. It is one of the few parenteral options for a patient with suspected HIT, so a recall lands on the pharmacy and the bedside at once.
What was found
Par identified the particles as cellulose, polystyrene, polyethylene terephthalate, stopper material and possibly stainless steel. The company said that giving product that contains particulate matter "has a reasonable probability of causing life-threatening adverse health consequences," including pulmonary emboli, occlusion of other blood vessels that can lead to tissue death and organ damage, and inflammation of vein walls that may lead to clotting.
Par said it has not received any reports of adverse events related to the recall. The recall is being conducted with FDA's knowledge. The agency's posting reproduces the company's announcement and does not yet list a recall classification.
The drug in question is the one a team reaches for when heparin is no longer an option, which is why the lot check belongs in this week's pharmacy huddle, not next month's.
Which lots
The recalled vials were distributed nationwide to wholesalers and hospitals between Dec. 30, 2024, and May 5, 2026, labeled as distributed by Par Pharmaceutical or Endo USA, predecessor companies of Par Health USA. Under National Drug Code 42023-182-01, the recalled lots are 83449, 82682, 86714, 87302, 87560, 87753, 88401, 88614, 88836, 90220, 91216, 91219, 92004, 92006, 92009, 92596, 92782, 93107, 93329 and 93890. Under NDC 42023-182-89, they are 84193 and 92880. Expiration dates run from October 2026 to September 2027. Check stock against the table and label images in the company's announcement rather than against this list alone.
Par is notifying wholesale and hospital accounts in writing and arranging returns through Inmar, Inc. Wholesalers and hospital pharmacies that have recalled product should stop using and distributing it immediately and notify any accounts they supplied, the company said.
What it means in clinic
For hospitalists, intensivists, cardiologists and hematologists, the first step is a question to pharmacy: do any vials on hand, in automated dispensing cabinets or in the cath lab match the recalled lots, and have they been pulled? The second is supply. If unaffected argatroban is short, pharmacy and therapeutics committees will decide on alternatives, and order sets and dosing references may change with them. The announcement gives no instructions for patients who already received drug from an affected lot; suspected reactions and quality problems go to FDA's MedWatch program.
Recall questions go to Inmar at 1-855-648-7909. Medical and technical questions, product complaints and adverse event reports go to Par at 1-800-828-9393. Drug-safety actions are arriving at a steady pace this fall; our report on FDA's new boxed warning for Injectafer is another one for the pharmacy committee's agenda.
Reported, fact-checked and edited by The Script Pad's editorial staff.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
