Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in...
FDA Recall #D-0186-2025 — Class II — December 27, 2024
Product Description
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
Reason for Recall
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
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
17,300 10-mL vials
Distribution
Distributed Nationwide in the USA.
Code Information
Batch # 1PR24010, Expiry: 02/28/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated