medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose V...
FDA Recall #D-0185-2025 — Class II — December 18, 2024
Product Description
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
Reason for Recall
CGMP Deviations
Recalling Firm
Eugia US LLC — East Windsor, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
19872 vials
Distribution
Nationwide in the US
Code Information
Lot No.: 1MP24069, Exp.: 08/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated