Denver Solutions, LLC DBA Leiters Health recalls Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compa
Recalled March 6, 2024 · FDA recall D-0363-2024 · Denver Solutions, LLC
Hazard
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. · FDA Class II
Units
40,890 vials
Sold at
Nationwide in the USA
Description
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
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
Manufacturer(s)
Denver Solutions, LLC DBA Leiters Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →