Recall D-0277-2024
Description: FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
Recall D-0277-2024 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0277-2024 |
Event ID | 93710 |
Distribution | Nationwide within the United States |
Quantity | 8,976 IV bags |
Recall Reason | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. |
Drug Classification | Class I |
Drug Code Info | 20240207 |
Recall Initiation Date | 20231228 |
Report Date | 20240207 |
Classification Date | 20240129 |
Address | 13796 Compark Blvd Englewood, CO 80112-7145 United States |
Recalling Firm | Denver Solutions, LLC DBA Leiters Health |
Initial Notification | |
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