Eugia US LLC

6 recalls on record

Class II2025-06-25

Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.

Eugia US LLCdrug

Class II2025-05-07

Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Eugia US LLCdrug

Class II2025-05-07

Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Eugia US LLCdrug

Class II2025-04-23

Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Eugia US LLCdrug

Class II2025-01-15

Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

Eugia US LLCdrug

Class II2025-01-15

medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India

CGMP Deviations

Eugia US LLCdrug