FDAHealthMarch 31, 2025
Denver Solutions, LLC DBA Leiters Health — 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 Compar
⚠️ Lack of Assurance of Sterility: Leaking/damaged syringes.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 31, 2025
Nationwide in the U.S.A
What's affected?
- 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.
- Lot code
- 2431276A
Additional details
Lot #: 2431276A, Exp.: 4/20/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 23,610 syringes.
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