Denver Solutions, LLC DBA Leiters Health recalls dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe,
Recalled April 30, 2025 · FDA recall D-0371-2025 · Denver Solutions, LLC
Hazard
Lack of Assurance of Sterility: Leaking/damaged syringes. · FDA Class II
Units
23,610 syringes
Sold at
Nationwide in the U.S.A
Description
Lack of Assurance of Sterility: Leaking/damaged syringes.
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.
Manufacturer(s)
Denver Solutions, LLC DBA Leiters Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →