Drug recall D-0472-2025

Class II Ongoing reported Jun 25, 2025

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.

Lots and codes

Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025

Recall details

Recalling firm
Eugia US LLC, East Windsor, NJ
Quantity
48,000 vials
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
May 29, 2025

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