BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc.,
Summary
The FDA issued a Class I for BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufacture by Scynexis, Inc.. Reason: Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial bet.
Details
Source
Drug Recall
External ID
D-0042-2024
Action Date
2023-10-18
Status
Completed
Category
drug
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
Lot/Code Info: Lot# LF21000008, Exp. 11/30/2023 Lot# LF22000051, Exp. 11/30/2025
Quantity Affected: 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).
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-25
Company
Jersey City, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 76 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Scynexis, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Scynexis, Inc. have FDA actions?
This is the only FDA action we have on record for Scynexis, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0042-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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