Antifungal Tablets Under Class I Recall

Cross-contamination concerns have prompted a Class I recall for two lots of Brexafemme (ibrexafungerp) tablets, according to the October 18, 2023, US Food and Drug Administration (FDA) Enforcement Report. The FDA’s most serious recall classification, a Class I designation warns use of the affected drug could cause serious adverse health consequences or death.

“During a review of manufacturing equipment and cleaning activities at a supplier, [recalling firm] Scynexis was made aware of potential cross-contamination risk with a nonantibacterial beta-lactam drug substance,” Scynexis Inc. announced in a September 27, 2023, statement.

The recall affects 150-mg Brexafemme tablets in 4-count cartons (NDC 75788-115-04) from lots LF21000008 (Exp. 11/30/23) and LF22000051 (Exp. 11/30/25). The affected tablets were manufactured for and distributed by Scynexis Inc., Jersey City, New Jersey, throughout the US.

Scynexis voluntarily initiated the recall September 25, 2023. The FDA issued its Class I designation on October 6, 2023.

“The potential cross contamination with a nonantibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria, and anaphylaxis, a potentially life-threatening adverse reaction,” the statement explained. “To date, Scynexis has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.”

Brexafemme is an antifungal prescription drug indicated for treating vulvovaginal candidiasis and reducing the incidence of recurrent vulvovaginal candidiasis.