Why it was recalled
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
Lot numbers, UPCs & expiration codes
Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0472-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 29, 2025
- FDA report date
- Jun 25, 2025
- Quantity
- 48,000 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0472-2025, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96976
- Address
- 279 Princeton Hightstown Rd
- Code information
- Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
- Postal code
- 08520-1401
- Report date
- Jun 25, 2025
- Product type
- Drugs
- Recall number
- D-0472-2025
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- May 29, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 18, 2025