FDA recall D-0624-2024

Product

Progesterone Injection, USP, 500 mg 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: Complaint received of a glass particle in the vial.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-07-26

Report date

2024-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0624-2024