Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0277-2024
Event ID93710
DistributionNationwide within the United States
Quantity8,976 IV bags
Recall ReasonSuperpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Drug ClassificationClass I
Drug Code Info20240207
Recall Initiation Date20231228
Report Date20240207
Classification Date20240129
Address13796 Compark Blvd
Englewood, CO 80112-7145
United States
Recalling FirmDenver Solutions, LLC DBA Leiters Health
Initial Notification E-Mail
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