Eugia US LLC: Drug Recall

Recall #D-0472-2025 · 05/29/2025

Class II: Risk

Recall Details

Recall Number: D-0472-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Eugia US LLC
Status: Ongoing
Date Initiated: 05/29/2025
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 48,000 vials

Reason for Recall

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

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Eugia US LLC

Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 04/10/2025

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II: Risk 12/27/2024

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class II: Risk 12/18/2024

CGMP Deviations

View all recalls by Eugia US LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.