Drug recall D-0385-2024

Class II Terminated reported Mar 20, 2024

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.

Reason for recall

Failed Stability Specification: Water determination was found not complying with specification.

Lots and codes

Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.

Recall details

Recalling firm
Eugia US LLC, East Windsor, NJ
Quantity
1160 VIALS
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 22, 2024
Terminated
December 22, 2025

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