FDA recall D-0072-2024

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

Product

VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.

Reason for recall

Labeling: Not Elsewhere Classified

Distribution

USA Nationwide

Key facts

Status
Terminated
Initiation date
2023-10-04
Report date
2023-11-01
Termination date
2024-08-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0072-2024