D-0472-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 25, 2025
- Initiation Date
- May 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,000 vials
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.
Distribution Pattern
Nationwide in the USA
Code Information
Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025