Tobramycin Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 55150-470
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tobramycin (NDC 55150-470). A significant event, classified as Class II, was initiated on Feb 22, 2024 by Eugia Us Llc. The reported reason for this action was: "Failed Stability Specification: Water determination was found not complying with specification."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Stability Specification: Water determination was found not complying with specification.
Feb 22, 2024
Mar 20, 2024
1160 VIALS
Recall Profile & Regulatory Data
Event ID
94081
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 22, 2025
Product Description
Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01.
Batch or Lot Expiration Information
Lot# s: 3TB23001, 3TB23002, Exp. 04/30/2025.
Affected Packages Involved in this Recall
55150-470-01Product
55150-470-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
