MedroxyPROGESTERone Acetate Injectable Suspension recalled over manufacturing violations

Recall date

December 18, 2024

Source

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

Official notice title

Eugia US LLC recalls medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for:…

Recall number

D-0185-2025

FDA classification

Class II

Brand / firm

Eugia US LLC

Sold / distributed

Nationwide in the US

Why it was recalled

CGMP Deviations

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

What was recalled

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