Class II Recall

Eugia US LLC

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
Reason
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Classification
Class II
Status
Ongoing
Lot
Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.