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Safety Report: BREXAFEMME® Antifungal oral medication - recalled due to Potential cross contamination, USA

1 year ago •source fda.gov

Recall notice

BREXAFEMME® Antifungal oral medication - recalled due to Potential cross contamination photo #1

United States

SCYNEXIS, Inc. is conducting a voluntary nationwide recall of 2 lots of BREXAFEMME® (ibrexafungerp tablets) to the consumer level in the US market due to potential cross contamination with a non- antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME® tablets. 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. To date, SCYNEXIS has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.

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.

BREXAFEMME® is an antifungal product indicated for the treatment of vulvovaginal candidiasis (VVC) and the reduction of the incidence of recurrent vulvovaginal candidiasis (RVVC).

BREXAFEMME® is dispensed in a carton and packaged in blister packs with four 150-mg tablets (NDC 75788-115-04). BREXAFEMME® tablet for oral administration is a purple, oval, biconvex shaped, film-coated tablet debossed with 150 on one side and SCY on the other side. The affected BREXAFEMME® lots include the following lots and expiration dates: LF21000008 (expiration date 11/2023) and LF22000051 (expiration date 11/2025). The recalled lots were distributed nationwide to wholesalers across the US, beginning in December 2022.

SCYNEXIS is engaging with Sedgwick to manage the recall of the product down to the consumer level. Sedgwick will be notifying BREXAFEMME® distributors via a recall notification letter and will be arranging for the return of the recalled lot from distributors, retailers, and consumers.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Scynexis, Inc.
Brand name: Brexafemme
Product recalled: Antifungal oral medication
Reason of the recall: Potential cross contamination with non-antibacterial beta-lactam drug substance
FDA Recall date: September 28, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/scynexis-issues-voluntary-nationwide-recall-brexafemmer-ibrexafungerp-tablets-due-potential-cross

#drugs #recall #us

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