FDAFDA · Food and drugs·Recall number 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 55150-401-25
Published June 25, 2025 · Recall initiated: May 29, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GENTAMICIN
- Manufacturer
- Eugia US LLC
- Distributor
- Nationwide in the USA
- Lot
- Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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