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Denver Solutions, LLC DBA Leiters Health recalls VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark B

Recalled February 7, 2024 · FDA recall D-0282-2024 · 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
7,548 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
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
Manufacturer(s)
Denver Solutions, LLC DBA Leiters Health

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov