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Eugia US LLC FDA Recalls
17 recalls on file across drugs, 1 of them Class I and 16 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US Class IIIMay 18, 2026Labeling: Not Elsewhere Classified: The label wrap covers th |
| Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India foClass IIMay 29, 2025Failed Stability Specifications: Out of specification resul |
| Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured Class IIApr 21, 2025Out-of-Specification test results were obtained in at long t |
| Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in Class IIApr 21, 2025Out-of-Specification test results were obtained in at long t |
| Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, Class IIApr 10, 2025cGMP: complaints of crystals not redissolving into solution |
| Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLClass IIDec 27, 2024Presence of Particulate Matter: A market complaint was recei |
| medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Class IIDec 18, 2024CGMP Deviations |
| Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US Class IIJul 26, 2024Presence of Particulate Matter: Complaint received of a glas |
| Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed byClass IIMay 23, 2024Failed Impurities/Degradation Specifications: impurity sulfo |
| Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E.Class IIIMay 22, 2024Failed Impurities/Degradation Specifications: failed related |
| Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE Class IIFeb 22, 2024Failed Stability Specification: Water determination was foun |
| Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics PharmClass IIFeb 20, 2024Failed Impurities/Degradation Specifications: Out of specifi |
| Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 PrinClass IIFeb 20, 2024Failed Impurities/Degradation Specifications: Out of specifi |
| Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in Class IIFeb 20, 2024Failed Dissolution Specifications |
| Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. iClass IFeb 15, 2024Presence of Particulate Matter |
| Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For IClass IISep 28, 2023Presence of Particulate Matter: A product complaint of a pie |
| Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics PClass IIDec 28, 2022Presence of Particulate Matter: Customer complaint of dark p |