Recalls / Class II
Class IID-0371-2025
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.
- Affected lot / code info
- Lot #: 2431276A, Exp.: 4/20/2025
Why it was recalled
Lack of Assurance of Sterility: Leaking/damaged syringes.
Recalling firm
- Firm
- Denver Solutions, LLC DBA Leiters Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 13796 Compark Blvd, N/A, Englewood, Colorado 80112-7145
Distribution
- Quantity
- 23,610 syringes
- Distribution pattern
- Nationwide in the U.S.A
Timeline
- Recall initiated
- 2025-03-31
- FDA classified
- 2025-04-18
- Posted by FDA
- 2025-04-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0371-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.