Drug Enforcement D-0042-2024

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

Status

Completed

Classification

Class I

Report Date

October 18, 2023

Termination Date

—

Product Information

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
Product quantity
17,376
Reason for recall
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide in the US.

Location & Firm

Recalling firm
Scynexis, Inc.
Address
1 Evertrust Plz Fl 13, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0042-2024
Event ID
93113
Recall initiation date
September 25, 2023
Center classification date
October 6, 2023
Code info
Lot# LF21000008, Exp. 11/30/2023 Lot# LF22000051, Exp. 11/30/2025
More code info
—