# FDA recall D-0337-2018

> **AuroMedics Pharma LLC** · Class I · drug recall initiated 2017-12-20.

## Product

Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51

## Reason for recall

Presence of Particulate Matter; white particulate matter identified as mold was found in one bag

## Distribution

Product was distributed throughout United States.

## Key facts

- **Recall number:** D-0337-2018
- **Recalling firm:** AuroMedics Pharma LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-20
- **Report date:** 2018-02-14
- **Termination date:** 2019-06-24

- **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-0337-2018

## Citation

> AI Analytics. FDA recall D-0337-2018. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0337-2018. Source: US FDA. Licensed CC0.

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