Denver Solutions, LLC DBA Leiters Health recalls FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 1379
Recalled February 7, 2024 · FDA recall D-0278-2024 · Denver Solutions, LLC
Hazard
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. · FDA Class I
Units
13,920 IV bags
Sold at
Nationwide within the United States
Description
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Product
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
Manufacturer(s)
Denver Solutions, LLC DBA Leiters Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →