FDA recall D-0362-2024

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

Product

Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42

Reason for recall

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2024-02-20
Report date
2024-03-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0362-2024