Drug 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.
D-0385-2024
Product summary
- Firm
- Eugia US LLC
- Event
- Event 94081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1160 VIALS
- Official record key
drug-enforcement:D-0385-2024
Official wording
Reason: Failed Stability Specification: Water determination was found not complying with specification.
Code information: Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Stability Specification