FDAFDA · Food and drugs·Recall number 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
Published March 6, 2024 · Recall initiated: February 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Distributor
- Nationwide in the USA
- Lot
- Lot #:2331104, Exp:9-Mar-24; 2331137, Exp: 3-Mar-24; 2331196, Exp: 11-Mar-24; 2331264, Exp: 6-Apr-24; 2331282, Exp: 18-Apr-24; 2331464, Exp: 8-May-24; 2331481, Exp: 16-May-24; 2331500, Exp: 20-May-24.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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