Multi event Drug Recall Enforcement Report Class III voluntary initiated by Baxter Healthcare Corporation, originally initiated on 08-01-2018 for the product Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24. The product was recalled due to superpotent drug: high out of specification results for levofloxacin resulting in increased concentration of solution.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1034-2018 | 08-01-2018 | 08-15-2018 | Class III | 191,256 bags | Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24. | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Terminated |
| D-1036-2018 | 08-01-2018 | 08-15-2018 | Class III | 711,216 bags | Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24. | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Terminated |
| D-1035-2018 | 08-01-2018 | 08-15-2018 | Class III | 106,320 bags | Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24. | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. | Terminated |
Recalled Products
