# FDA recall D-0385-2024

> **Eugia US LLC** · Class II · drug recall initiated 2024-02-22.

## Product

Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01.

## Reason for recall

Failed Stability Specification: Water determination was found not complying with specification.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0385-2024
- **Recalling firm:** Eugia US LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-02-22
- **Report date:** 2024-03-20
- **Termination date:** 2025-12-22

- **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-0385-2024

## Citation

> AI Analytics. FDA recall D-0385-2024. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/D-0385-2024. Source: US FDA. Licensed CC0.

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