Recall Enforment Report D-0071-2024
Recall Details
Multi event Drug Recall Enforcement Report Class III voluntary initiated by Denver Solutions, LLC DBA Leiters Health, originally initiated on 10-04-2023 for the product VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68. The product was recalled due to labeling: not elsewhere classified. 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-0071-2024 | 10-04-2023 | 11-01-2023 | Class III | 33,480 IV Bags | VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68. | Labeling: Not Elsewhere Classified | Ongoing |
D-0070-2024 | 10-04-2023 | 11-01-2023 | Class III | 6,276 IV bags | Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70 | Labeling: Not Elsewhere Classified | Ongoing |
D-0072-2024 | 10-04-2023 | 11-01-2023 | Class III | 25,908 IV bags | VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68. | Labeling: Not Elsewhere Classified | Ongoing |