Tobramycin for Injection — Class II drug recall D-0385-2024
Terminated recall by Eugia US LLC, reported 2024-03-20, distributed nationwide. Failed Stability Specification: Water determination was found not complying with specification.
| Recall number | D-0385-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eugia US LLC, East Windsor, NJ, United States |
| Recall initiated | 2024-02-22 |
| Classified | 2024-03-14 |
| Reported by FDA | 2024-03-20 |
| Terminated | 2025-12-22 |
| Distributed | Nationwide (US) |
| Quantity | 1,160 vials |
| Reason classes | specification failure |
| NDC | 55150-0470, 55150-0470-01, 55150-0470-06 |
| Lot numbers | 3TB23001, 3TB23002 |
| Expiration dates | 2025-04-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0385-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.