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Par Health Recalls Dexmedetomidine Injection Over Contamination Risks

Potential life-threatening complications have prompted Par Health to issue a voluntary nationwide recall of two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride injection. The move follows the discovery of particulate matter, identified as cellulose or stopper material, within the intravenous sedative used in intensive care and surgical settings.

Par Health Recalls Dexmedetomidine Injection Over Contamination Risks

The recall affects lot numbers 87558 and 88802, which were distributed to wholesalers across the United States between May 13 and June 29, 2025. While Par Health reports no adverse events linked to the affected vials to date, the company warns that the presence of particulates poses serious health risks. These include pulmonary emboli, vessel occlusions that can trigger tissue death or organ damage, and venous inflammation leading to clotting.

Medical facilities and wholesalers currently holding these specific lots are instructed to discontinue use and halt distribution immediately. Par Health is coordinating with Inmar, Inc. to facilitate the return of the inventory. Hospitals and clinics with questions regarding returns or product safety can contact Inmar or the manufacturer directly, or submit reports through the FDA’s MedWatch program.

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