Last Updated on October 2, 2023 by The Health Master
Drug recall: 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.
This press release provides additional details on the voluntary drug recall recently disclosed by Scynexis.
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.
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 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 drug recall lots were distributed nationwide to wholesalers across the US, beginning in December 2022.
This drug recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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