FDA recall D-0363-2024

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

Product

Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42

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-0363-2024