Recall D-0374-2025
Description: Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
Recall D-0374-2025 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0374-2025 |
Event ID | 96607 |
Distribution | Nationwide in the U.S.A |
Quantity | 16,655 syringes |
Recall Reason | Lack of Assurance of Sterility: Leaking/damaged syringes. |
Drug Classification | Class II |
Drug Code Info | 20250430 |
Recall Initiation Date | 20250331 |
Report Date | 20250430 |
Classification Date | 20250418 |
Address | 13796 Compark BlvdN/A Englewood, CO 80112-7145 United States |
Recalling Firm | Denver Solutions, LLC DBA Leiters Health |
Initial Notification | Letter |
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