D-0385-2024 Class II Terminated
FDA drug recall D-0385-2024 was initiated by Eugia US LLC on February 22, 2024 and is designated Class II. Reason for recall: Failed Stability Specification: Water determination was found not complying with specification. The recall status is terminated (terminated December 22, 2025). Affected quantity: 1160 VIALS.
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2024
- Initiation Date
- February 22, 2024
- Termination Date
- December 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1160 VIALS
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.
Reason for Recall
Failed Stability Specification: Water determination was found not complying with specification.
Distribution Pattern
Nationwide
Code Information
Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.