Product: dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
Reason for recall: Lack of Assurance of Sterility: Leaking/damaged syringes.
Recall initiated: 20250331
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated