# FDA recall D-0555-2024

> **Eugia US LLC** · Class II · drug recall initiated 2024-05-23.

## Product

Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30

## Reason for recall

Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0555-2024
- **Recalling firm:** Eugia US LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-05-23
- **Report date:** 2024-06-26

- **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-0555-2024

## Citation

> AI Analytics. FDA recall D-0555-2024. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0555-2024. Source: US FDA. Licensed CC0.

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