Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India fo
Summary
The FDA issued a Class II for Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Sin by Eugia US LLC. Reason: Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis..
Details
Source
Drug Recall
External ID
D-0472-2025
Action Date
2025-06-25
Status
Ongoing
Category
drug
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/Code Info: Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
Quantity Affected: 48,000 vials
Reason for Recall
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-29
Company
East Windsor, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 76 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Eugia US LLC has 17 FDA actions in our database, including 17 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Eugia US LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Eugia US LLC have FDA actions?
Eugia US LLC has 17 FDA actions in our database, including 17 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0472-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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