FDAFDA · Food and drugs·Recall number D-0385-2024
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.
Published March 20, 2024 · Recall initiated: February 22, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specification: Water determination was found not complying with specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TOBRAMYCIN
- Manufacturer
- Eugia US LLC
- Distributor
- Nationwide
- UPC
- 0355150470013
- Lot
- Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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