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Recall Observatory FDA recall evidence

Drug 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

D-0472-2025

May 29, 2025

Class II

Product summary

Firm
Eugia US LLC
Event
Event 96976
Status
Ongoing
Classification
Class II
Quantity
48,000 vials
Official record key
drug-enforcement:D-0472-2025

Official wording

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

Code information: Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification