Par Pharmaceutical (Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion/Par Health) Recall reason: Presence of particulate[...]

COMPANY ANNOUNCEMENT

Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter

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Summary

Company Announcement

ROCHESTER, MI- September 18, 2026 -Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose or stopper material.

Administration of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 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.

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) is formulated for intravenous infusion. The product is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting and for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.

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

These lots were distributed nationwide to wholesalers between May 13, 2025 and June 29, 2025.

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 87558 and 88802 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 1-833-599-3197 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:

• Content current as of:

  09/21/2026

• Regulated Product(s)

  • Drugs

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