FDA recall D-0186-2025

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 for recall

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

Distribution

Distributed Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2024-12-27

Report date

2025-01-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0186-2025