D-0371-2025 Class II Ongoing
FDA drug recall D-0371-2025 was initiated by Denver Solutions, LLC DBA Leiters Health on March 31, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Leaking/damaged syringes. The recall status is ongoing. Affected quantity: 23,610 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2025
- Initiation Date
- March 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,610 syringes
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.
Reason for Recall
Lack of Assurance of Sterility: Leaking/damaged syringes.
Distribution Pattern
Nationwide in the U.S.A
Code Information
Lot #: 2431276A, Exp.: 4/20/2025