FDA recall D-0879-2023

Product

Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03

Reason for recall

cGMP deviations: potential for Microbial Contamination of Non-Sterile Products

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2023-06-12

Report date

2023-07-05

Termination date

2024-08-05

Voluntary/Mandated

N/A

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0879-2023