Drug recall
Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY…
FDA recall event 94081 · Class II · Eugia US LLC
Key facts
| Event ID | 94081 |
|---|---|
| Recall numbers | D-0385-2024 |
| Recalling firm | Eugia US LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Stability Specification: Water determination was found not complying with specification. |
| Initiation date | Feb 22, 2024 |
| Report date | Mar 20, 2024 |
| City | East Windsor |
| State | NJ |
| Country | United States |
| FEI number | 3014054088 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: