Endometrin Vaginal Insert 100mg recalled over sterility concerns

Recall date

June 12, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ferring Pharmaceuticals Inc recalls Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal a…

Recall number

D-0879-2023

FDA classification

Class II

Brand / firm

Ferring Pharmaceuticals Inc

Sold / distributed

USA Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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