# FDA recall D-0574-2018

> **AuroMedics Pharma LLC** · Class I · drug recall initiated 2018-01-12.

## Product

Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810  Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ----  NDC 55150-243-46

## Reason for recall

Presence of Particulate Matter; contains visible particulate matter identified as mold.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0574-2018
- **Recalling firm:** AuroMedics Pharma LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-12
- **Report date:** 2018-03-07
- **Termination date:** 2020-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0574-2018

## Citation

> AI Analytics. FDA recall D-0574-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0574-2018. Source: US FDA. Licensed CC0.

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