Drug Enforcement D-0472-2025

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

Status

Ongoing

Classification

Class II

Report Date

June 25, 2025

Termination Date

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Product Information

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
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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Eugia US LLC
Address
279 Princeton Hightstown Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0472-2025
Event ID
96976
Recall initiation date
May 29, 2025
Center classification date
June 18, 2025
Code info
Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
More code info
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