Par Health recalls two lots of dexmedetomidine infusion due to particulate contamination
Par Health announced a voluntary recall of two lots of its dexmedetomidine HCl in 0.9% sodium chloride injection, which is used for intravenous sedation.
The recall was initiated after testing identified particulate matter, described as cellulose or stopper material, in the product.
Regulators warned that such particles could potentially cause life‑threatening events such as pulmonary emboli, vascular occlusions or vein inflammation, although no adverse events have been reported to date.
The recall is being carried out at the hospital level, and the company has not received any reports of related health issues.
This writeup was produced by pharmadog from original reporting by fda recalls.
Original headline: “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”
read at fda recalls ↗
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