Par Health 因检出纤维素颗粒物自愿全国召回两批 Brevital Sodium 500 mg/vial（批号 86930、88623）

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 08, 2026

FDA Publish Date:

October 09, 2026

Product Type:

Drugs

Reason for Announcement:

Recall Reason Description

Presence of particulate matter identified as cellulose

Company Name:

Par Health

Brand Name:

Brand Name(s)

Par Pharmaceutical

Product Description:

Product Description

Brevital Sodium 500 mg/vial for Injection

Company Announcement

FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 8, 2026 –Par Health is voluntarily recalling two lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose.

Administration of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP), 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.

Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) is formulated for intravenous infusion in adult patients or intramuscular induction in pediatric patients. The product is indicated as an ultra-short-acting barbiturate anesthetic primarily used for the induction of anesthesia and procedural sedation.

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

These lots were distributed nationwide to wholesalers between July 8, 2025 and May 11, 2026.

Par Health is providing written notification to wholesale accounts that have received the affected lots and are arranging for return of all existing inventory of Lots 86930 and 88623 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 1-844-774-1187 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 examples of vial labels from the affected lots below: