In a Class I recall, the most serious type, a New Jersey drugmaker is removing 17,376 drug cartons from the market because of a cross-contamination risk.
Scynexis is recalling two lots of Brexafemme (ibrexafungerp) tablets 150 milligram, 4 count cartons. The antifungal drug is approved for vulvovaginal candidiasis.
The possible cross-contamination risk is with ezetimibe, a non-antibacterial beta-lactam compound that could lead to swelling, rash, hives, anaphylaxis and a life-threatening reaction, according to the FDA. No adverse events have been reported.