Data Composite

Recall D-0371-2025

US Class II Ongoing · initiated 2025-03-31

Recalling firm

Denver Solutions, LLC DBA Leiters Health, CO

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.

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