Class II
Ongoing
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
This recall is currently active, issued June 25, 2025. It was issued by Eugia Us Llc.
- Company
- Eugia Us Llc
- Recall Initiated
- May 29, 2025
- Posted
- June 25, 2025
- Recall Number
- D-0472-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 48,000 vials
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Distribution
Nationwide in the USA
Lot / Code Info
Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
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