FDA Drug recall D-1036-2018
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, Manufactur…
- 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, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactur… 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-1036-2018 |
| 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, 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.
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 #: A060940, A060948, A060951, A060956, A060958, A060963, Exp 07/18; A061105, A061110, A061113, A061115, A061119, Ex…Lot #: A060940, A060948, A060951, A060956, A060958, A060963, Exp 07/18; A061105, A061110, A061113, A061115, A061119, Exp 08/18; A061243, Exp 09/18; A0A0813, Exp 07/19; A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925, Exp 08/19; A0A0971, A0A0976, Exp 09/19; A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, A0A1004, 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-1036-2018%22
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