VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only;...
FDA Recall #D-0281-2024 — Class I — December 28, 2023
Product Description
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 for Recall
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Recalling Firm
Denver Solutions, LLC DBA Leiters Health — Englewood, CO
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
10,152 IV bags
Distribution
Nationwide within the United States
Code Information
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated