FDA-Drug2024-03-06Class II
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
Denver Solutions, LLC DBA Leiters Health
Hazard
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Sold states
Nationwide in the USA
Affected count
40,890 vials
Manufactured in
13796 Compark Blvd, Englewood, CO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0363-2024Don't want to check this manually?
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