Class II
Drug Recall: 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,
Eugia US LLC · February 22, 2024
Reason for Recall
Failed Stability Specification: Water determination was found not complying with specification.
Product 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.
Distribution
Nationwide
States Affected
NATIONWIDE
Quantity Affected
1160 VIALS
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0385-2024
Status: terminated
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