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.
Recall initiated: 20240222
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated