Class II
Ongoing
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
This recall is currently active, issued March 6, 2024. It was issued by Denver Solutions, Llc Dba Leiters Health.
- Recall Initiated
- February 20, 2024
- Posted
- March 6, 2024
- Recall Number
- D-0363-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 40,890 vials
- Firm Location
- Englewood, CO, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Distribution
Nationwide in the USA
Lot / Code Info
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.
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