SCYNEXIS, Inc. announced that it is conducting a voluntary nationwide recall of 2 lots of BREXAFEMME® (ibrexafungerp tablets) to the consumer level in the US market due to potential cross contamination with a non-antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME® tablets. During a review of manufacturing equipment and cleaning activities at a supplier, SCYNEXIS was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance. This press release provides additional details on the voluntary product recall recently disclosed by SCYNEXIS.

Risk Statement: The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction. To date, SCYNEXIS has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination. SCYNEXIS is engaging with Sedgwick to manage the recall of the product down to the consumer level.

Sedgwick will be notifying BREXAFEMME® distributors via a recall notification letter and will be arranging for the return of the recalled lot from distributors, retailers, and consumers.