Eugia US LLC recalls
13 recalls on record · FDA
Every recall we have on record for Eugia US LLC, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx…
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose…
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container…
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial,…
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only,…
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx…
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL…
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by:…
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, …
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For…
Failed Stability Specification: Water determination was found not complying with specification.
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL…
Failed Dissolution Specifications
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL…
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx…
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial