FDAFDA · Food and drugs·Recall number D-0371-2025
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.
Published April 30, 2025 · Recall initiated: March 31, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Leaking/damaged syringes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Distributor
- Nationwide in the U.S.A
- Lot
- Lot #: 2431276A, Exp.: 4/20/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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