FDA recall D-0042-2024

Product

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

Reason for recall

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

Distribution

Nationwide in the US.

Key facts

Status

Completed

Initiation date

2023-09-25

Report date

2023-10-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jersey City, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0042-2024