Home / Recalls / Eugia US LLC / D-0555-2024

D-0555-2024 Class II Ongoing

Recalled by Eugia US LLC — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
June 26, 2024
Initiation Date
May 23, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70,125 vials

Product Description

Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30

Reason for Recall

Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.

Distribution Pattern

USA Nationwide

Code Information

Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024

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  • 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-0556-2024 Class III — Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. (May 22, 2024)
  • D-0385-2024 Class II — Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For (February 22, 2024)
  • D-0391-2024 Class II — Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distri (February 20, 2024)