SCYNEXIS Issues a Voluntary Nationwide Recall of BREXAFEMME® (ibrexafungerp tablets) due to potential for cross contamination with a non-antibacterial ß-lactam drug substance
During a review of manufacturing equipment and cleaning activities at a supplier, SCYNEXIS was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance.
- During a review of manufacturing equipment and cleaning activities at a supplier, SCYNEXIS was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance.
- This press release provides additional details on the voluntary product recall recently disclosed by SCYNEXIS.
- Risk Statement: The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction.
- To date, SCYNEXIS has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.