American biotech company Scynexis has issued a voluntary nationwide recall of two lots of Brexafemme (ibrexafungerp tablets) to the consumer level in the US market due to the risk of cross contamination.
Brexafemme is an antifungal product. It is intended to treat vulvovaginal candidiasis (VVC) and lower the incidence of recurrent vulvovaginal candidiasis (RVVC).
Scynexis has recalled the drug over the potential risk of cross contamination with a non-antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the tablets.
The drug was licensed for commercialisation by British drugmaker GSK in March this year for an upfront payment of $90m.
According to the biotech firm, cross contamination with a non-antibacterial beta-lactam medication ingredient can cause hypersensitivity reactions like swelling, rash, urticaria, and anaphylaxis.
As of now, SCYNEXIS has not received any reports of side effects that were linked to possible beta-lactam cross contamination.
The company is recalling the Brexafemme distributed nationwide to wholesalers across the US, commencing in December last year. The affected lots include the LF21000008 lot with an expiration date of 11/2023 and the LF22000051 lot with an expiration date of 11/2025.
The oral antifungal medicine is distributed in a carton and packaged in blister packs with four 150-mg tablets. It is a purple, oval, biconvex-shaped, film-coated pill debossed with 150 on one side and SCY on the opposite side.
Scynexis is collaborating with Sedgwick to manage the recall of the product from the consumer level.
Sedgwick will arrange for the return of the recalled lot from distributors, retailers, and customers and will notify Brexafemme distributors via a recall notification letter.
The US-based firm suggested that users get in touch with their doctor if they have any issues related to consuming or using the product. The company is conducting the recall with the knowledge of the US Food and Drug Administration (FDA).
