Class IIReported 2025-06-25

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

Reason for Recall

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.

Recall Number

D-0472-2025

Classification

Class II

Status

Ongoing