Cross-Contamination Leads to Recall of Two Lots of Brexafemme
Contamination of Brexafemme with a non-antibacterial beta-lactam drug could lead to reactions such as swelling, rash, urticaria and anaphylaxis.
Scynexis is recalling two lots of Brexafemme (ibrexafungerp) because of the potential for cross-contamination. Brexafemme is a non-azole antifungal approved to treat and prevent recurrent vaginal yeast infections. It is the only treatment for vaginal yeast infections that is both oral and non-azole. It has broad activity on a range of Candida species, including azole-resistant strains.
During a review of manufacturing equipment at a supplier, it was discovered there could be potential cross-contamination with a non-antibacterial beta-lactam drug. This could lead to reactions such as swelling, rash, urticaria and anaphylaxis. To date, Scynexis has not received any reports of adverse events because of possible beta-lactam cross contamination.
Brexafemme is packaged in blister packs with four 150-mg tablets (NDC 75788-115-04). The affected lots include the following lots include LF21000008 with an expiration date of November 2023 and LF22000051 with an expiration date of November 2025. The recalled lots were distributed nationwide to wholesalers across the United States beginning in December 2022.
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