Recall Enforment Report D-0363-2024
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Denver Solutions, LLC DBA Leiters Health, originally initiated on 02-20-2024 for the 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 The product was recalled due to presence of particulate matter: glass vials from the manufacturer showed signs of glass delamination.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0363-2024 | 02-20-2024 | 03-06-2024 | Class II | 40,890 vials | 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 | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. | Ongoing |
D-0362-2024 | 02-20-2024 | 03-06-2024 | Class II | 10,020 vials | Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42 | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. | Ongoing |
D-0361-2024 | 02-20-2024 | 03-06-2024 | Class II | 40,090 vials | Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42 | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. | Ongoing |