FDAHealthMay 29, 2025
Eugia US LLC — 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, Ca
⚠️ Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 29, 2025
Nationwide in the USA
What's affected?
- 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
- Brand
- GENTAMICIN
- Lot code
- Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
Additional details
Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 48,000 vials.
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