VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.

Recall Number: D-0281-2024

Firm: Denver Solutions, LLC DBA Leiters Health

Classification: Class I

Status: Ongoing

Report Date: 20240207

Initiation Date: 20231228

Termination Date:

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.