Drug 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
D-0472-2025
Product summary
- Firm
- Eugia US LLC
- Event
- Event 96976
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48,000 vials
- Official record key
drug-enforcement:D-0472-2025
Official wording
Reason: Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Code information: Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification