FDA Drug recall D-1034-2018
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…
- FDA Drug
- Class III
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class III recall of 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… by Baxter Healthcare, citing superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1034-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-01 |
| Published | 2018-08-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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.
Reason
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Identifiers
| ndc | 36000-045-01 |
|---|---|
| ndc | 36000-046-24 |
| ndc | 36000-047-24 |
| ndc | 36000-048-24 |
| code_info | Lot #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1034-2018%22
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