Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion
Product details
- Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion
Company announcement
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.
These lots were distributed nationwide to wholesalers between May 13, 2025 and June 29, 2025.
To date, Par Health has not received any reports of adverse events related to this recall.
Risk:
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.
Impacted states: Nationwide
Products:
- Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL)
- Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL)
Contact
For more information, call 1-833-599-3197 or email rxrecalls@inmar.com.
Related recalls
- 0.9% Sodium Chloride Injection, USP, 100 mL
- Compounded Glutathione 200 mg/mL 30 mL multidose vial; Myer’s Cocktail 30 mL multidose vial; Tri-Immune Boost 30 mL multidose vial
- Luna G3 APAP (Model LG3600)
- 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
- 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
- 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container