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.
FDA recall notice · announced March 20, 2024 · Eugia Us
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Notes
Distribution: Nationwide
Lot/code information: Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.
Quantity: 1160 VIALS
Status: Terminated
Products in this recall event:
- 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, (D-0385-2024)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.