Brexafemme tablets recall overview:
- Who: Pharma company SCYNEXIS has initiated a voluntary recall for two lots of its Brexafemme antifungal tablets.
- Why: The recall was initiated over concern the Brexafemme antifungal tablets may have been cross contaminated with a non-antibacterial beta-lactam drug substance.
- Where: Nationwide.
Pharma company SCYNEXIS has initiated a voluntary nationwide recall for two lots of its Brexafemme antifungal tablets over concerns they may have been cross contaminated with a non-antibacterial beta-lactam drug substance.
The recall, which was published by the U.S. Food and Drug Administration on Sept. 28, is to the consumer level for the antifungal oral medication.
SCYNEXIS said it was made aware of a possible cross contamination during a review of the manufacturing equipment and cleaning activities at one of its suppliers, according to the recall.
“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,” SCYNEXIS said.
SCYNEXIS has not received any reports of adverse health effects in connection with Brexafemme recall
SCYNEXIS said it has not received any reports of adverse health effects in connection with the Brexafemme recall, and advised consumers to contact their healthcare provider if they had any issues that may be related to taking or using the product.
The company is working with the global claims management solutions company Sedgwick to manage the recall down to the consumer level, according to the Brexafemme recall.
Individuals with more questions about the recall can contact Sedgwick directly by telephone at 1-877-551-7154.
In other antifungal-related news, a class action lawsuit was filed against the makers of Lotrimin and Tinactin antifungal spray products earlier this month over claims they failed to disclose that the products allegedly contained dangerous levels of the cancer-causing chemical benzene.
Are you affected by the Brexafemme tablets recall? Let us know in the comments!
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