Par Health Issues Nationwide Recall of Two Lots of Dexmedetomidine HCl
核心洞察
Par Health (搜索) is voluntarily recalling two lots of Dexmedetomidine HCl (搜索) in 0.9% Sodium Chloride Injection 400 mcg/100 mL to the hospital level nationwide.
The recall follows identification of particulate matter described as cellulose or stopper material in the intravenous infusion product.
The affected lots, 87558 and 88802, were distributed to wholesalers nationwide between May 13, 2025 and June 29, 2025.
Par Health (搜索) is voluntarily recalling two lots of Dexmedetomidine HCl (搜索) in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The recall covers Lots 87558 and 88802, which were distributed nationwide to wholesalers between May 13, 2025 and June 29, 2025. Particulate matter identified as cellulose or stopper material was found in the product.
The company states that administration of the affected product has a reasonable probability of causing life-threatening adverse health consequences, including pulmonary emboli (搜索), occlusion of other blood vessels that can lead to tissue death and possible organ damage, and inflammation of vein walls that may lead to clotting. Par Health (搜索) has not received any reports of adverse events related to the recall to date.
The product is formulated for intravenous infusion and is indicated for sedation of initially intubated and mechanically ventilated adult patients in intensive care, and for sedation of non-intubated adult patients before or during surgical and other procedures. Par Health (搜索) is notifying wholesale accounts that received the affected lots and is arranging returns through Inmar, Inc. (搜索) Distributors and hospital pharmacies holding the product should stop use and distribution immediately and notify any accounts that received further shipments. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (搜索).
Source: PR Newswire