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FDARecalled Mar 20, 2024 · #D-0385-2024

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 0852...

Hazard

Class II — temporary health risk

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Description

Failed Stability Specification: Water determination was found not complying with specification. Classification: Class II Distribution: Nationwide

Product details

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.
Type
Drugs
Manufacturer
Eugia US LLC
Model numbers
UPCs