Recall D-0472-2025

US Class II Ongoing · initiated 2025-05-29

Recalling firm

Eugia US LLC, NJ

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.

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