Status
Ongoing
Drug Enforcement D-0371-2025
Lack of Assurance of Sterility: Leaking/damaged syringes.
Classification
Class II
Report Date
April 30, 2025
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 23,610 syringes
- Reason for recall
- Lack of Assurance of Sterility: Leaking/damaged syringes.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the U.S.A
Location & Firm
- Recalling firm
- Denver Solutions, LLC DBA Leiters Health
- Address
-
13796 Compark Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0371-2025
- Event ID
- 96607
- Recall initiation date
- March 31, 2025
- Center classification date
- April 18, 2025
- Code info
- Lot #: 2431276A, Exp.: 4/20/2025
- More code info
- —