Eugia US LLC: Drug Recall

Recall #D-0185-2025 · 12/18/2024

Class II: Risk

Recall Details

Recall Number: D-0185-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Eugia US LLC
Status: Ongoing
Date Initiated: 12/18/2024
Location: East Windsor, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 19872 vials

Reason for Recall

CGMP Deviations

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

Distribution Pattern

Nationwide in the US

Other Recalls by Eugia US LLC

Class II: Risk 05/29/2025

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 04/21/2025

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II: Risk 04/10/2025

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II: Risk 12/27/2024

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

View all recalls by Eugia US LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.