Drug recall
Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use…
FDA recall event 80653 · Class III · Baxter Healthcare Corporation
Key facts
| Event ID | 80653 |
|---|---|
| Recall numbers | D-1034-2018, D-1035-2018, D-1036-2018 |
| Recalling firm | Baxter Healthcare Corporation |
| Product type | Drugs |
| Products | 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…, 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…, 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. |
| Initiation date | Aug 1, 2018 |
| Report date | Aug 15, 2018 |
| Termination date | Jul 16, 2020 |
| City | Deerfield |
| State | IL |
| Country | United States |
| FEI number | 1417572 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: