Recalling firm
Eugia US LLC
Product type
Drug
Status
Ongoing
Report date
2025-06-25
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
48,000 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason 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
Code / lot info
Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.