FDA-Drug2025-06-25Class II
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
Eugia US LLC
Hazard
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Sold states
Nationwide in the USA
Affected count
48,000 vials
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0472-2025Don't want to check this manually?
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