FDARecalled Mar 6, 2024 · #D-0363-2024
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
Hazard
Class II — temporary health risk
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Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. Classification: Class II Distribution: Nationwide in the USA
Product details
- 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
- Type
- Drugs
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Model numbers
- 2331104
- UPCs
- —