Par Health 因检出微粒物质自愿全国召回22个批次 Argatroban 注射液

COMPANY ANNOUNCEMENT

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:

October 13, 2026

FDA Publish Date:

October 14, 2026

Product Type:

Drugs

Reason for Announcement:

Recall Reason Description

Presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel

Company Name:

Par Health USA, LLC

Brand Name:

Brand Name(s)

Par Health and Endo USA

Product Description:

Product Description

Argatroban Injection 250 mg/2.5 mL (100 mg/mL)

Company Announcement

FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 13, 2026 – Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level. This recall is being conducted due to the presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel, that was detected in certain lots.

Administration of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting. To date, Par Health has not received any reports of adverse events related to this recall.

Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a direct thrombin inhibitor indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention.

Recalled product can be identified as follows and by representative labels at bottom of this document:

These lots were distributed nationwide to wholesalers and hospitals between December 30, 2024, and May 5, 2026.

Par Health is providing written notification to wholesale and hospital accounts that have received the affected lots and is arranging for return of all existing inventory through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

Questions regarding this recall can be directed to Inmar, Inc. at 1-855-648-7909 Monday through Friday between the hours of 9 a.m. and 5 p.m. ET or by email at [email protected].

For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393 Monday through Thursday between the hours of 9 a.m. and 8 p.m. ET or Friday between 9 a.m. and 6 p.m. ET.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Package Identification:
See representative examples of vial labels from selected affected lots below:

Contacts
Gena Holthaus, Senior Director, Corporate Brand and Communications
[email protected]

*Par Pharmaceutical, Inc. and Endo USA, Inc. are predecessor companies to Par Health USA, LLC, the current distributor of the product.

Company Contact Information

Consumers:

Inmar, Inc.

1-855-648-7909