FDA Recall D-0042-2024
Scynexis, Inc. · Jersey City, NJ
Class I — life-threatening Completed 962 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
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 record
- Recall number
D-0042-2024- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide in the US.
- Recall initiated
- 2023-09-25
- Classified by FDA Center
- 2023-10-06
- FDA published
- 2023-10-18
- Recalling firm
- Scynexis, Inc.
- Firm location
- Jersey City, NJ