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

Recall Number: D-0363-2024

Firm: Denver Solutions, LLC DBA Leiters Health

Classification: Class II

Status: Ongoing

Report Date: 20240306

Initiation Date: 20240220

Termination Date:

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

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