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TOPIC: Two Lots of Brevital Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) by Par Health: Recall - Due to the Presence of Particulate Matter

AUDIENCE: Patient, Health Care Professional, Risk Manager, Pharmacy, Cardiology, Pulmonology

ISSUE: Par Health is recalling two lots of Brevital Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) to the hospital level 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.

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

To date, Par Health has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: 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.

RECOMMENDATIONS: 

• 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 at 1-844-774-1187 or by email at rxrecalls@inmar.com.

• For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download the form or call 1-800-332-1088 to request a reporting form, then complete it and return it to the address on the form or submit it by fax to 1-800-FDA-0178.

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