Recall Enforment Report D-0277-2024
Recall Details
Multi event Drug Recall Enforcement Report Class I voluntary initiated by Denver Solutions, LLC DBA Leiters Health, originally initiated on 12-28-2023 for the product FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41. The product was recalled due to superpotent drug: semi-automated iv bag filling system can malfunction and provide a double dose of drug product to iv bags.. 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-0277-2024 | 12-28-2023 | 02-07-2024 | Class I | 8,976 IV bags | FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Ongoing |
D-0282-2024 | 12-28-2023 | 02-07-2024 | Class I | 7,548 IV bags | VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Ongoing |
D-0279-2024 | 12-28-2023 | 02-07-2024 | Class I | 29,016 IV bags | PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Ongoing |
D-0280-2024 | 12-28-2023 | 02-07-2024 | Class I | 12,564 IV bags | PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Ongoing |
D-0281-2024 | 12-28-2023 | 02-07-2024 | Class I | 10,152 IV bags | VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Ongoing |
D-0278-2024 | 12-28-2023 | 02-07-2024 | Class I | 13,920 IV bags | FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82. | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. | Ongoing |