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
Reason for recall: Failed Stability Specifications:  Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Recall initiated: 20250529
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated