Recalls / Class II
Class IID-0385-2024
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.
- Brand name
- Tobramycin
- Generic name
- Tobramycin
- Active ingredient
- Tobramycin Sulfate
- Route
- Intravenous
- NDC
- 55150-470
- FDA application
- ANDA217519
- Affected lot / code info
- Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.
Why it was recalled
Failed Stability Specification: Water determination was found not complying with specification.
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 1160 VIALS
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2024-02-22
- FDA classified
- 2024-03-14
- Posted by FDA
- 2024-03-20
- Terminated
- 2025-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0385-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.