Recall: D-0186-2025

Class II - Potentially Harmful

Class IIClassification

2024-12-27Initiated

OngoingStatus

Eugia US LLCFirm

Product

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

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

Distribution

Distributed Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.