FDA-Drug2024-03-20Class II
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.
Eugia US LLC
Hazard
Failed Stability Specification: Water determination was found not complying with specification.
Sold states
Nationwide
Affected count
1160 VIALS
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
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, Carton NDC 55150-470-06, Vial NDC 55150-470-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0385-2024Don't want to check this manually?
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