FDA recall D-0281-2024

Denver Solutions, LLC DBA Leiters Health · Class I · drug

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 for recall

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

Distribution

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2023-12-28
Report date: 2024-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0281-2024