Anaphylaxis Risk Prompts Nationwide Recall of BREXAFEMME® Tablets
JERSEY CITY, N.J., September 27, 2023 — SCYNEXIS, Inc. has initiated a voluntary recall spanning the entire nation for two lots of BREXAFEMME® (ibrexafungerp tablets) at the consumer level in the U.S. The recall arises due to concerns of potential cross contamination with a non-antibacterial beta-lactam compound found in the ibrexafungerp citrate utilized in manufacturing BREXAFEMME® tablets.
The potential contamination was identified during an inspection of manufacturing equipment and cleanliness protocols at a supplier’s facility, informing SCYNEXIS of the probable risk of contamination with a non-antibacterial beta-lactam compound. This article offers supplementary details regarding the voluntary recall as recently disclosed by SCYNEXIS.
This potential contamination with a non-antibacterial beta-lactam compound might provoke hypersensitivity reactions in some individuals, including swelling, rashes, urticaria, and potentially severe and life-threatening reaction known as anaphylaxis. At present, no reports of adverse reactions attributable to potential beta-lactam cross contamination have been received by SCYNEXIS.
BREXAFEMME® is a medication prescribed for the management of vulvovaginal candidiasis (VVC) and to decrease the occurrence of recurrent vulvovaginal candidiasis (RVVC). BREXAFEMME® comes in cartons, enclosed in blister packs containing four 150-mg tablets (NDC 75788-115-04). The tablets are purple, oval, biconvex, film-coated, with 150 debossed on one side and SCY on the other side. The concerned lots are LF21000008 (expires 11/2023) and LF22000051 (expires 11/2025), which were distributed nationwide to wholesalers across the U.S. starting in December 2022.
For the initiation of this recall at the consumer level, SCYNEXIS is collaborating with Sedgwick. Distributors of BREXAFEMME® will receive recall notification letters from Sedgwick, who will also manage the return of the recalled lots from distributors, retailers, and consumers.
Individuals who may have encountered any issues related to the consumption of this medication should consult their healthcare provider promptly.
Any adverse reactions or quality problems related to the use of this product can be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail, or by fax. This recall is being conducted in collaboration with and with the knowledge of the U.S. Food and Drug Administration.
How to File Your Claim
Victims and their families who have been adversely affected by the recalled BREXAFEMME® can seek legal counsel with Parker Waichman LLP, a renowned national product injury law firm. The firm can guide victims through the legal process to file a lawsuit for seeking damages due to potential health complications and other losses related to the use of this medication.
Parker Waichman LLP possesses extensive experience in product liability lawsuits, especially concerning medical products and medications. They can offer invaluable assistance in understanding the legal rights of the victims and determining the viability of their case. The firm meticulously investigates each case, collecting the necessary evidence, and establishing a strong connection between the injury and the defective product, to ensure that their clients secure the justice they deserve.
Victims of defective products can recover various damages, including medical expenses incurred for treating the adverse effects, loss of wages due to inability to work, pain and suffering endured, and, in severe cases, compensation for long-term impairment or permanent disabilities. In instances where a family member succumbs to complications arising from defective products, the family can file a wrongful death lawsuit to recover damages, including funeral expenses, loss of companionship, and loss of financial support.
It is crucial for victims and their families to act promptly and reach out to Parker Waichman LLP to discuss their case. The firm offers a free consultation to victims when they call 1-800-YOUR-LAWYER (1-800-968-7529), providing them with an opportunity to understand their legal options without any obligation. Choosing to pursue legal action with Parker Waichman LLP can be a step towards obtaining rightful compensation and holding the responsible parties accountable for the harm caused by the defective product.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
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