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

FDA recall notice · announced October 18, 2023 · Scynexis

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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).

Notes

Distribution: Nationwide in the US.
Lot/code information: Lot# LF21000008, Exp. 11/30/2023 Lot# LF22000051, Exp. 11/30/2025
Quantity: 17,376
Status: Completed
Products in this recall event:
- 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 (D-0042-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.