Reported Jun 25, 2025 · Ongoing
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India…
Eugia US LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Eugia US LLC · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd
- in India forEugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25
- Lot codes and dates
Batch 3GT230063GT230073GT23008
- Exp Date
November302025
- Amount recalled
- 48,000 vials
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
This product could cause temporary or reversible health problems — stop using it.
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