Par Pharmaceutical Recalls Two Lots of Dexmedetomidine HCl Injection Due to Particulate Matter

Par Pharmaceutical is voluntarily recalling two lots of its Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 400 mcg/100 mL (4 mcg/mL). The recall extends nationwide and is directed at the hospital level.

The reason for the recall is the identification of particulate matter within the injectable solution. The company has not specified the nature of the particulates or potential health risks but has initiated the recall to ensure patient safety.

Dexmedetomidine hydrochloride is an anesthetic agent used for sedation and anesthesia in hospital settings. It is administered intravenously.

Healthcare facilities are urged to stop using the affected lots immediately and return any unused product. Par Pharmaceutical has notified the Food and Drug Administration (FDA) of this voluntary recall.