FDA recall D-0371-2025

Denver Solutions, LLC DBA Leiters Health · Class II · drug

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.

Distribution

Nationwide in the U.S.A

Key facts

Status: Ongoing
Initiation date: 2025-03-31
Report date: 2025-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0371-2025