The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public about the marketing and sale of unregistered Menofix Composition.
NAFDAC received a complaint concerning the marketing and sale of Menofix Capsules. The complainant also raised concerns regarding possible liver-related adverse effects associated with some of the ingredients contained in the product.
Following investigation by the Post Marketing Surveillance Directorate, it was established that the complaint product, Menofix, is not registered with NAFDAC.
Further review found that the product being marketed differs from similarly named products already registered by the Agency. Two registered products with a similar name are Menofix Herbal Capsule (NAFDAC Reg. No. A7-103321L) and Menofix Powder (NAFDAC Reg. No. A7-103342L), both registered under the Herbal and Nutraceuticals category and manufactured by Gudugudu Herbal Worldwide Enterprises.
Menofix by Pure Eve is marketed as a hormone-free, vegetarian-friendly multivitamin and herbal supplement designed to help women navigate the physical and hormonal shifts of perimenopause and menopause.
It appears to be widely available for over-the-counter purchase, including through online channels and open retail outlets.
Risk Statement
As the complaint product Menofix is unregistered, it has not undergone NAFDAC evaluation for safety, quality, or efficacy. NAFDAC has therefore not verified claims associated with the product.
Additionally, some ingredients reportedly contained in the marketed Menofix product have been associated with rare reports of liver-related adverse effects, including hepatitis, elevated liver enzymes, jaundice, and, in very rare cases, liver failure.
Product details
The details of the counterfeit products are as follows:
Product Name: Menofix Capsules
Regulatory Status: Not registered with NAFDAC
Marketed by: PureEve (as stated in the investigation findings)
Product Photo
Monitoring is ongoing to get hold of the distribution line and resolve this issue. All NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance and remove the unregistered product if found within their zones and states.
Retailers, healthcare professionals, and consumers are hereby advised to avoid the sale, and use of unregistered product. All medical products must be purchased from authorized or licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, call NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices 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
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng
NAFDAC………. Customer-focused, Agency-minded!!!
