September 2023 FDA Recall Drug by Scynexis, Inc.
D-0042-2024 - Cross Contamination with Other Products

This Class I drug recall was voluntarily initiated by Scynexis, Inc. on September 25, 2023 for the product Drug. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0042-2024

Reason for Recall
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Initiated
09-25-2023
Reported
10-18-2023
Quantity
17,376

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93113
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Scynexis, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US.
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# LF21000008, Exp. 11/30/2023
Lot# LF22000051, Exp. 11/30/2025