Home / Recalls / Eugia US LLC / D-0385-2024

D-0385-2024 Class II Terminated

Recalled by Eugia US LLC — East Windsor, NJ

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.

Other recalls by Eugia US LLC

  • D-0472-2025 Class II — Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Sin (May 29, 2025)
  • D-0389-2025 Class II — Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose co (April 21, 2025)
  • D-0390-2025 Class II — Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose (April 21, 2025)
  • D-0363-2025 Class II — Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-D (April 10, 2025)
  • D-0186-2025 Class II — Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, (December 27, 2024)
  • D-0185-2025 Class II — medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 (December 18, 2024)
  • D-0624-2024 Class II — Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Via (July 26, 2024)
  • D-0555-2024 Class II — Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Mul (May 23, 2024)
  • D-0556-2024 Class III — Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. (May 22, 2024)
  • D-0391-2024 Class II — Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distri (February 20, 2024)