FDA-Drug2025-04-30Class II
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.
Denver Solutions, LLC DBA Leiters Health
Hazard
Lack of Assurance of Sterility: Leaking/damaged syringes.
Sold states
Nationwide in the U.S.A
Affected count
23,610 syringes
Manufactured in
13796 Compark Blvd, N/A, Englewood, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0371-2025Don't want to check this manually?
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