# FDA recall D-0556-2022

> **AuroMedics Pharma LLC** · Class I · drug recall initiated 2022-01-26.

## Product

Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10

## Reason for recall

Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0556-2022
- **Recalling firm:** AuroMedics Pharma LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-26
- **Report date:** 2022-02-16
- **Termination date:** 2024-08-20

- **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-0556-2022

## Citation

> AI Analytics. FDA recall D-0556-2022. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0556-2022. Source: US FDA. Licensed CC0.

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