The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public that Scynexis, Inc is conducting a voluntary nationwide recall of two (2) lots of BREXAFEMME® (ibrexafungerp tablets) 150 mg to the consumer level in the US market as reported by the United States (US) Food and Drug Administration (FDA).
This recall is due to potential cross contamination with a non- antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME tablets. Scynexis was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance during a review of manufacturing equipment and cleaning activities at a supplier.
BREXAFEMME® is an antifungal product indicated for the treatment of vulvovaginal candidiasis (VVC) and the reduction of the incidence of recurrent vulvovaginal candidiasis (RVVC).
Possible risk: 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.
Product Details
The details of the affected lots are as follows;
Product Name:
Brexafemme (ibrexafungerp tablets) 150 mg
Product Manufacturer: Scynexis, Inc
Active Pharmaceutical Ingredient: Ibrexafungerp citrate
Product Description: purple, oval, biconvex shaped, film-coated tablet debossed with 150 on one side and SCY on the other side.
| Batch number | Expiry date | First distributed |
| LF21000008 | 11/2023 | December 2022 |
| LF22000051 | 11/2025 | December 2022 |
Product Image:
It should be noted that Brexafemme (ibrexafungerp tablets) 150 mg
is not registered by NAFDAC.
Although the product is not in NAFDAC database, it is likely that it might have been distributed in the country through informal markets.
NAFDAC implores importers, distributors, retailers and healthcare providers and patients to always exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and administration or use of falsified or substandard medicinal products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
If you have this falsified product, please DO NOT use it. If you, or someone you know, have used the product, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC……….Customer-focused, Agency-minded!!!
Signed Management
References
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/scynexis-issues-voluntary-nationwide-recall-brexafemmer-ibrexafungerp-tablets-due-potential-cross#:~:text=%C3%9Flactam%20Drug%20Substance-,SCYNEXIS%20Issues%20a%20Voluntary%20Nationwide%20Recall%20of%20BREXAFEMME%C2%AE%20(ibrexafungerp,announcement%20as%20a%20public%20service.
Brexafemme Recalled Due to Possible Cross Contamination Issue
