DexmedeTOMIDine HCl PF recalled over sterility concerns

Recall date

March 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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,…

Recall number

D-0371-2025

FDA classification

Class II

Brand / firm

Denver Solutions, LLC DBA Leiters Health

Sold / distributed

Nationwide in the U.S.A

Why it was recalled

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.