TL;DR
Par Health USA is recalling 22 lots of argatroban injection distributed to U.S. wholesalers and hospitals after particulate matter was detected in certain lots. The company says the particles could pose a risk of life-threatening harm and that it has received no reports of related adverse events so far.
Par Health USA, LLC has announced a voluntary nationwide recall of 22 lots of Argatroban Injection after particulate matter was detected in certain lots, according to a company announcement posted by the U.S. Food and Drug Administration on October 14. The company says use of affected product could cause life-threatening complications; it reports receiving no adverse-event reports related to the recall to date.
The recall covers Argatroban Injection 250 mg/2.5 mL (100 mg/mL), distributed under the Par Health and Endo USA names. The company said the particles identified included cellulose, polystyrene, polyethylene terephthalate and stopper material, with stainless steel also a possibility. The FDA page describes the notice as a company announcement and says it posts such announcements as a public service; it does not endorse the company or product.
The affected lots were distributed nationwide to wholesalers and hospitals from December 30, 2024, through May 5, 2026. The announcement lists lot numbers and expiration dates for the recalled product. The notice identifies two National Drug Codes, 42023-182-0183 and 42023-182-8984, and directs hospitals and wholesale distributors to compare their inventory with the listed lot information.
Par Health said it is notifying wholesale and hospital accounts that received the affected lots and arranging returns through Inmar, Inc. It instructed distributors and hospital pharmacies to stop using and distributing recalled product immediately. Accounts that passed product on to other locations are asked to notify those recipients. The notice says the recall is being conducted with FDA’s knowledge.
Risks for Patients and Hospitals
Argatroban is a direct thrombin inhibitor used to prevent or treat thrombosis in adults with heparin-induced thrombocytopenia (HIT), and as an anticoagulant for adults with or at risk for HIT undergoing percutaneous coronary intervention. Because the recalled medicine is used in hospital care for patients who need anticoagulation, identifying and removing affected lots from clinical inventories is the immediate focus of the notice.
Par Health warns that injecting product containing particulate matter carries a reasonable probability of life-threatening adverse health consequences. The company lists possible pulmonary emboli, blockage of other blood vessels that could cause tissue death or organ damage, and inflammation of vein walls that may lead to clotting. These are risks cited in the recall announcement, not reports that such outcomes have occurred in patients connected with this recall.
The company says it has received no reports of adverse events related to the recall as of its announcement. That statement reflects the information reported by Par Health at that time; it does not establish that no patient was exposed or that no later reports will be made. The recall provides hospitals and distributors a way to check stock, stop further use and arrange returns.
As an affiliate, we earn on qualifying purchases.
What the Recall Covers
The FDA posted the notice on October 14, one day after the company’s October 13 announcement. The recall is at the hospital/user level, and applies to 22 listed lots of one product strength and presentation: 250 mg in 2.5 mL, at a concentration of 100 mg/mL. The notice says product was distributed across the country over a period of more than a year.
Par Health USA is identified as the current distributor. The announcement notes that Par Pharmaceutical, Inc. and Endo USA, Inc. are predecessor companies to Par Health USA, LLC, which helps explain why recalled packaging may show Par Pharmaceutical or Endo USA. The product’s distributor name and the lot number should be checked together against the recall list rather than relying on brand name alone.
The source notice gives contact details for recall coordination and for medical or technical product questions. It also directs users to FDA’s MedWatch program to report adverse reactions or product quality problems. The notice does not say that all vials are affected; it specifies the listed lots.
“The recall is being conducted due to the presence of particulate matter … that was detected in certain lots.”
— Par Health, in the company announcement
As an affiliate, we earn on qualifying purchases.
Exposure and Patient Reports
The announcement does not say how many vials or patients may have been affected, how many units remain in circulation, or whether any recalled product was administered. Par Health reports no related adverse-event reports to date, but the notice does not provide independent findings about patient exposure or clinical outcomes.
The source also does not explain how the particles entered the product, whether the issue is limited to the listed lots for a particular manufacturing reason, or when the investigation will be complete. It identifies the types of particulate matter found or possibly present, but does not provide details about the detection process or quantities. Further information from the company or regulators may clarify those points.
injectable anticoagulant medication
As an affiliate, we earn on qualifying purchases.
As an affiliate, we earn on qualifying purchases.
Return and Reporting Steps
Wholesalers and hospital pharmacies should check stock against the lot numbers and expiration dates in the FDA-posted company notice, stop use and distribution of affected product, and follow Par Health’s return arrangements through Inmar. Accounts that redistributed the product should notify any additional locations that may have received it.
Questions about the recall can be directed to Inmar at 1-855-648-7909, Monday through Friday, 9 a.m. to 5 p.m. Eastern time, or by email at rxrecalls@inmar.com. For medical or technical product information, or to report a product complaint or adverse event, the announcement lists Par Health’s number as 1-800-828-9393, available Monday through Thursday from 9 a.m. to 8 p.m. Eastern and Friday from 9 a.m. to 6 p.m.
The company also directs people to FDA MedWatch for reporting adverse reactions or quality problems. The announcement does not provide a deadline for completing returns or state when further investigation results will be released. Hospitals and distributors should follow the recall instructions and consult appropriate clinical or pharmacy staff about affected inventory.
medical particulate matter testing kits
As an affiliate, we earn on qualifying purchases.
As an affiliate, we earn on qualifying purchases.
Key Questions
Which argatroban injection is being recalled?
The recall covers Argatroban Injection 250 mg/2.5 mL (100 mg/mL) distributed under Par Health or Endo USA names, in the 22 lots listed in the company notice. Check the lot number and expiration date against that list.
Why did Par Health recall the product?
Par Health said particulate matter was detected in certain lots. The company identified cellulose, polystyrene, polyethylene terephthalate and stopper material, and said stainless steel was also possible.
What should hospitals and distributors do?
The company says wholesalers and hospital pharmacies should stop using and distributing affected lots, arrange returns through Inmar, and notify any other accounts or locations to which they sent the product.
Have adverse events been reported?
Par Health said it had received no reports of adverse events related to the recall as of its October 13 announcement. The notice does not say whether affected product was administered or whether later reports have been received.
Where can recall questions or product problems be reported?
Recall questions can be directed to Inmar at 1-855-648-7909 or rxrecalls@inmar.com. Par Health lists 1-800-828-9393 for medical or technical questions and product complaints; the announcement also directs adverse-event and quality reports to FDA MedWatch.
Source: primary
