Recall: D-0385-2024

Class II - Potentially Harmful

Class IIClassification

2024-02-22Initiated

TerminatedStatus

Eugia US LLCFirm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.