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fda recalls·3d ago·1 min read
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Par Health recalls two lots of dexmedetomidine infusion due to particulate contamination

Sep 18, 2026·read at fda recalls ↗CRLNegative

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.

source

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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companies & drugs in this story

companies
Par Pharmaceutical Inc
drugs
RNS-608SODIUM CHLORIDE8dexmedetomidine7
topics
Recall8Pulmonology3Hematology2

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