FDA-Drug2025-01-15Class II

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

Eugia US LLC
Hazard

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

Sold states
Distributed Nationwide in the USA.
Affected count
17,300 10-mL vials
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0186-2025

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