Recalls / Class II
Class IID-0472-2025
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
- Brand name
- Gentamicin
- Generic name
- Gentamicin
- Active ingredient
- Gentamicin Sulfate
- Route
- Intramuscular, Intravenous
- NDC
- 55150-401
- FDA application
- ANDA215236
- Affected lot / code info
- Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
Why it was recalled
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 48,000 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-05-29
- FDA classified
- 2025-06-18
- Posted by FDA
- 2025-06-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0472-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.