Scynexis, Inc. recalls BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc.…

Recall date

September 25, 2023

Source

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

Recall number

D-0042-2024

FDA classification

Class I

Brand / firm

Scynexis, Inc.

Sold / distributed

Nationwide in the US.

Why it was recalled

Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04