Class I Recall

Denver Solutions, LLC DBA Leiters Health

Product
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.
Reason
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Classification
Class I
Status
Ongoing
Lot
Lot #: 2331184, Exp. Date 02/13/2024; 2331185, Exp. Date 02/10/2024; 2331189, Exp. Date 02/20/2024; 2331191, Exp. Date 02/24/2024; 2331258,Exp. Date 03/03/2024; 2331317, Exp. Date 03/15/2024.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.