Par Health issued a voluntary nationwide recall of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection after particulate matter was identified in the hospital sedation drug, the Food and Drug Administration announced on Sept. 22.
The recall covers 400 mcg/100 mL vials used for intravenous infusion in intensive care units and hospital settings, according to the FDA. The particulate matter was described as cellulose or stopper material found in the injectable product.
Dexmedetomidine is widely used for ICU sedation and procedural sedation in hospitals. Particulate contamination in injectable drugs can cause vessel blockage, inflammatory response, organ damage or death, particularly in critically ill patients who are already in fragile health states, the FDA said.
The recall is nationwide in scope, affecting hospitals and ICUs across the United States. Hospital pharmacies are advised to immediately identify and quarantine affected lots, according to the recall notice.
Particulate matter in injectable drugs is a recurring quality-control challenge in pharmaceutical manufacturing. Contamination can occur through equipment failure, degradation of vial components or manufacturing process breakdowns.
The affected product is administered intravenously, meaning any particulate material enters the bloodstream directly. For ICU patients — who typically have compromised organ function and limited physiological reserves — the risk of adverse outcomes from IV particulate contamination is particularly acute.
Par Health is advising healthcare providers to visually inspect vials before use and to report any adverse events to the FDA’s MedWatch program. The company said it is working with distributors to ensure affected lots are removed from hospital supply chains.
The FDA said it would continue to monitor the recall and provide updates as warranted. Healthcare facilities that have administered doses from affected lots should monitor patients for signs of infusion-related reactions.
The recall notice includes specific lot numbers and expiration dates for the affected product.