FDA recall D-0472-2025

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 for recall

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-05-29

Report date

2025-06-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0472-2025