Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
SCYNEXIS issued the recall of 2 lots of BREXAFEMME (ibrexafungerp tablets) due to Potential for cross contamination with a non-antibacterial ßlactam ((beta lactam) drug substance. SCYNEXIS became aware of the cross contamination risk during review of manufacturing equipment and cleaning activities at a supplier. The potential cross contamination can lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis.
BREXAFEMME® is an antifungal product indicated for the treatment of vulvovaginal candidiasis (VVC). The recall will be managed by Sedgwick.
Leave a Comment
You must be logged in to post a comment.