D-0042-2024 Class I
FDA drug recall D-0042-2024 was initiated by Scynexis, Inc. on September 25, 2023 and is designated Class I. Reason for recall: Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound). Affected quantity: 17,376.
Recall Details
- Product Type
- Drugs
- Report Date
- October 18, 2023
- Initiation Date
- September 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,376
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
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 Pattern
Nationwide in the US.
Code Information
Lot# LF21000008, Exp. 11/30/2023 Lot# LF22000051, Exp. 11/30/2025