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
Reported: June 25, 2025 Initiated: May 29, 2025 #D-0472-2025
Product Description
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.
Details
- Recalling Firm
- Eugia US LLC
- Units Affected
- 48,000 vials
- Distribution
- Nationwide in the USA
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Eugia US LLC. Units affected: 48,000 vials.
Why was this product recalled? ▼
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 25, 2025. Severity: Moderate. Recall number: D-0472-2025.
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