PlainRecalls
FDA Drug Critical Class I Completed

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

Reported: October 18, 2023 Initiated: September 25, 2023 #D-0042-2024

Product Description

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).

Details

Recalling Firm
Scynexis, Inc.
Units Affected
17,376
Distribution
Nationwide in the US.
Location
Jersey City, NJ

Frequently Asked Questions

What product 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. Recalled by Scynexis, Inc.. Units affected: 17,376.
Why was this product recalled?
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Which agency issued this recall?
This recall was issued by the FDA Drug on October 18, 2023. Severity: Critical. Recall number: D-0042-2024.