February 2024 FDA Recall Tobramycin by Eugia Us Llc
D-0385-2024 - Failed Stability Specification
This Class II drug recall was voluntarily initiated by Eugia Us Llc on February 22, 2024 for the product Tobramycin. The FDA reported the reason for recall as failed stability specification. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0385-2024
Failed Stability Specification: Water determination was found not complying with specification.
02-22-2024
03-20-2024
1160 VIALS
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Eugia US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
12-22-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
