TL;DR
Get oils, diffusers and self-care delivered free with Prime
- Fast, free delivery on millions of items
- Prime Video, Amazon Music and more included
- Member-only deals all year
Par Health USA is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL because particulate matter was found in certain lots. The company says the material could pose a risk of life-threatening complications if injected, but it has received no reports of related adverse events to date. Hospitals and wholesalers should stop using and distributing affected lots and arrange returns.
Par Health USA has announced a voluntary nationwide recall of 22 lots of Argatroban Injection 250 mg/2.5 mL after particulate matter was detected in certain lots. The company says injection of affected product could cause life-threatening complications, including pulmonary emboli, while reporting that no related adverse events have been reported to date.
The recalled medicine is a direct thrombin inhibitor used in adults for the prevention or treatment of thrombosis associated with heparin-induced thrombocytopenia (HIT), and as an anticoagulant for adults with or at risk for HIT who are undergoing percutaneous coronary intervention. The product is labeled for distribution by Par Pharmaceutical or Endo USA, predecessor companies to Par Health USA, LLC.
Par Health identified the particles as cellulose, polystyrene, polyethylene terephthalate and stopper material, with stainless steel also considered a possibility. The recall covers specified lot numbers and expiration dates, rather than every unit of argatroban injection. The affected lots were distributed to wholesalers and hospitals nationwide from December 30, 2024, through May 5, 2026.
The company says the recall is being conducted to the hospital and user level. It is notifying wholesale and hospital accounts that received affected lots and arranging returns through Inmar, Inc. Wholesalers and hospital pharmacies with recalled product are instructed to stop use and distribution immediately, and to notify any accounts or additional locations to which they sent the medicine.
Risks for Patients Receiving Argatroban
The recall matters because the product is an injectable anticoagulant used in adult patients with HIT, a condition involving low platelet counts and a risk of blood clots. Affected medicine may already be held by hospitals or pharmacies because the recalled lots were distributed over more than a year and a half. The company’s notice directs healthcare supply-chain users to check lot details and halt distribution of any matching inventory.
Par Health warns that injecting product containing particulate matter carries a reasonable probability of life-threatening adverse health consequences. It lists pulmonary emboli, blockages in other blood vessels that could result in tissue death or organ damage, and inflammation of vein walls that may lead to clotting. These are risks stated in the recall notice, not reports that such outcomes have occurred in this recall. The company says it has received no adverse-event reports related to the recall so far.
Because this medicine is used in clinical care, the immediate notice is directed primarily at wholesalers, hospital pharmacies and other healthcare users. The announcement tells those organizations to stop use and distribution of affected lots. Patients with questions can contact the recall line, while medical or technical questions and product complaints can be directed to Par Health’s product-information contact. The notice does not provide patient-specific treatment advice.
As an affiliate, we earn on qualifying purchases.
Which Lots Are Included
The FDA’s October 14 posting reproduces a company recall announcement dated October 13. The agency describes its role in posting company announcements as a public service and says it does not endorse the product or company. The announcement states that the recall is being conducted with the FDA’s knowledge.
The product is identified as Argatroban Injection 250 mg/2.5 mL (100 mg/mL), with NDC 42023-182-0183. The listed affected lots and expiration dates are: 4491, October 2026; 82682, November 2026; 86714, February 2027; 87302, February 2027; 87560, February 2027; 87753, March 2027; 88401, March 2027; 88614, April 2027; 88836, April 2027; 90220, May 2027; 91216, June 2027; 91219, June 2027; 92004, July 2027; 92006, July 2027; 92009, August 2027; 92596, August 2027; 92782, August 2027; 93107, August 2027; 93329, August 2027; and 93890, September 2027.
The notice also lists NDC 42023-182-8984 with lots 1931, expiring October 2026, and 92880, expiring August 2027. The full NDC, lot and expiration information should be checked against the recall notice and vial labels; the recall applies to the listed lots, not simply to all product bearing the brand or medicine name.
““To date, Par Health has not received any reports of adverse events related to this recall.””
— Par Health, in its recall announcement
hospital grade argatroban injection
As an affiliate, we earn on qualifying purchases.
As an affiliate, we earn on qualifying purchases.
What the Recall Notice Does Not Establish
The announcement identifies the types of particulate matter detected but does not say how the contamination occurred, how many vials contained particles, or whether any affected vials reached patients. It also does not provide details about testing methods or the investigation into the source of the material. Those points are not established by the recall notice.
Par Health reports no adverse-event reports related to the recall as of its announcement. That is a statement about reports received by the company, not confirmation that every affected unit was unused or that no event could be reported later. The company’s warning describes potential consequences of injecting contaminated product; it does not say that those effects have been observed in this case.
The FDA posting is identified as a public-service publication of the company’s announcement. The notice says the recall is being conducted with the agency’s knowledge, but it does not describe a separate FDA investigation or an agency determination about the cause or extent of contamination.
As an affiliate, we earn on qualifying purchases.
Returns and Reporting Contacts
Par Health says it is notifying affected wholesale and hospital accounts and arranging returns through Inmar, Inc. Wholesalers and hospital pharmacies should immediately stop using and distributing affected product, check inventory against the listed NDCs and lots, and pass the recall notice to any accounts or locations that received further shipments.
Questions about the recall or returns 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, complaints or adverse events, Par Health lists 1-800-828-9393, available Monday through Thursday from 9 a.m. to 8 p.m. Eastern Time and Friday from 9 a.m. to 6 p.m.
The company also directs people to report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program, online, by mail or by fax. Further information about the recall’s scope, the investigation and any additional reports may emerge as the return and reporting process proceeds.
As an affiliate, we earn on qualifying purchases.
Key Questions
Which argatroban injection is being recalled?
The recall covers 22 specified lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL), with labels listing distribution by Par Pharmaceutical or Endo USA. Check the lot number, NDC and expiration date against the company’s recall notice; the announcement does not recall every lot of the medicine.
Why did Par Health issue the recall?
Par Health says particulate matter was detected in certain lots. The materials identified include cellulose, polystyrene, polyethylene terephthalate and stopper material; stainless steel is also listed as a possibility.
Have adverse events been reported?
Par Health says it had received no reports of adverse events related to the recall as of its October 13 announcement. The notice warns of potential serious consequences if affected product is injected, but does not report that those outcomes have occurred.
What should wholesalers and hospital pharmacies do?
The company instructs wholesalers and hospital pharmacies to immediately discontinue use and stop distribution of affected lots, notify any accounts or locations that received the product, and contact Inmar about returns.
Who can answer questions about the recall?
Inmar handles recall questions at 1-855-648-7909, Monday through Friday, 9 a.m. to 5 p.m. Eastern Time, and at rxrecalls@inmar.com. Par Health lists 1-800-828-9393 for medical or technical information, product complaints and adverse-event reports.
Source: primary
Halloween Picks
halloween
As an affiliate, we earn on qualifying purchases.
