Why it was recalled
Failed Stability Specification: Water determination was found not complying with specification.
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.
Lot numbers, UPCs & expiration codes
Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0385-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 22, 2024
- FDA report date
- Mar 20, 2024
- Quantity
- 1160 VIALS
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0385-2024, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 94081
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025.
- Postal code
- 08520-1401
- Report date
- Mar 20, 2024
- Product type
- Drugs
- Recall number
- D-0385-2024
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- Product quantity
- 1160 VIALS
- Termination date
- Dec 22, 2025
- Reason for recall
- Failed Stability Specification: Water determination was found not complying with specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 22, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2024