Progesterone Injection USP recalled over possible glass fragments

Recall date

December 27, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Eugia US LLC recalls Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US L…

Recall number

D-0186-2025

FDA classification

Class II

Brand / firm

Eugia US LLC

Sold / distributed

Distributed Nationwide in the USA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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