← FDA ENFORCEMENT
D-0042-2024Class I

Scynexis, Inc.

Recalling firm
Scynexis, Inc.
Product type
Drug
Status
Completed
Report date
2023-10-18
Distribution
Nationwide in the US.
Firm state
NJ
Product quantity
17,376
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.