# FDA recall D-1035-2018

> **Baxter Healthcare Corporation** · Class III · drug recall initiated 2018-08-01.

## Product

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.

## Reason for recall

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-1035-2018
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-01
- **Report date:** 2018-08-15
- **Termination date:** 2020-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1035-2018

## Citation

> AI Analytics. FDA recall D-1035-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1035-2018. Source: US FDA. Licensed CC0.

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