Levofloxacin Injection in 5% Dextrose — Class III drug recall D-1034-2018
Terminated recall by Baxter Healthcare Corporation, reported 2018-08-15, distributed nationwide. Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of s
| Recall number | D-1034-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2018-08-01 |
| Classified | 2018-08-03 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2020-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 191,256 bags |
| Reason classes | potency, specification failure |
| NDC | 36000-0045, 36000-0045-01, 36000-0046, 36000-0046-24, 36000-0047, 36000-0047-24, 36000-0048, 36000-0048-24 |
| Lot numbers | 08/19, 09/18, 10/19, A061178, A061183, A061236, A0A0937, A0A1044, A0A1048 |
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 for recall
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1034-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.