Class IIReported 2025-04-30

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.

Recalled by Denver Solutions, LLC DBA Leiters Health

Reason for Recall

Lack of Assurance of Sterility: Leaking/damaged syringes.

Recall Number

D-0371-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-03-31

Reported

2025-04-30

Distribution

Nationwide in the U.S.A

Code Info

Lot #: 2431276A, Exp.: 4/20/2025

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.