FDA Drug recall D-0385-2024
Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFU…
- FDA Drug
- Class II
- terminated
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class II recall of Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFU… by Eugia Us, citing failed Stability Specification: Water determination was found not complying with specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0385-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-02-22 |
| Published | 2024-03-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Eugia Us |
| Distribution | US |
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
Failed Stability Specification: Water determination was found not complying with specification.
Identifiers
| ndc | 55150-470-01 |
|---|---|
| ndc | 55150-470-06 |
| code_info | Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0385-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.