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FDARecalled Jun 25, 2025 · #D-0472-2025

Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 551...

Hazard

Class II — temporary health risk

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Description

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis. Classification: Class II Distribution: Nationwide in the USA

Product details

Product
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25
Type
Drugs
Manufacturer
Eugia US LLC
Model numbers
UPCs