TOBRAMYCIN SULFATE Recall D-0385-2024
Description: 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.
TOBRAMYCIN SULFATE Recall D-0385-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0385-2024 |
| Event ID | 94081 |
| Brand | TOBRAMYCIN |
| Generic Name | TOBRAMYCIN |
| Manufacturer | TOBRAMYCIN |
| Original Package? | 1 |
| Active Substance | TOBRAMYCIN SULFATE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide |
| Quantity | 1160 VIALS |
| Recall Reason | Failed Stability Specification: Water determination was found not complying with specification. |
| Drug Classification | Class II |
| Drug Code Info | 20240320 |
| Product NDC | 55150-470 |
| Drug UPC | 0355150470013 |
| Recall Initiation Date | 20240222 |
| Report Date | 20240320 |
| Classification Date | 20240314 |
| Address | 279 Princeton Hightstown Rd East Windsor, NJ 08520-1401 United States |
| Recalling Firm | Eugia US LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | HJT0RXD7JK |
| Drug Application Number | ANDA217519 |
| Structured Product Labeling (SPL ID) | c37c251f-92e9-40f0-8b0c-00d42875d776 |
| Structured Product Labeling (SPL Set ID) | c37c251f-92e9-40f0-8b0c-00d42875d776 |
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