FDA recall D-0361-2024

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

Product

Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42

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-0361-2024