Drug 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
D-0363-2024
Product summary
- Event
- Event 94071
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40,890 vials
- Official record key
drug-enforcement:D-0363-2024
Official wording
Reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Code information: 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.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter