The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public that Stuff by Nainax LLC is voluntarily recalling all lots of “MR.7 SUPER 700000’’ capsules to the consumer level over safety concerns.
The recall follows an FDA analysis, which found “MR.7 SUPER 700000’’ capsules to contain undeclared ingredients (tadalafil and sildenafil). Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction.
The presence of sildenafil and tadalafil in “MR.7 SUPER 700000’’ capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
MR.7 SUPER 700000 capsules are marketed online as a dietary supplement for male enhancement. Products containing sildenafil or tadalafil cannot be marketed as dietary supplements and could cause serious health risks.
RISK STATEMENT:
Consumption of products containing undeclared sildenafil or tadalafil may cause serious health risks. These ingredients may interact with nitrates found in certain prescription medications (such as nitroglycerin) and may result in a dangerous drop in blood pressure, which can be life-threatening. Individuals with diabetes, high blood pressure, high cholesterol, or heart disease frequently take nitrates. Adult males who use nitrates for cardiac conditions are at the greatest risk.
PRODUCT DETAILS:
Product Name: MR.7 SUPER 700000
Manufacturer’s Name: StuffbyNainax LLC
Batch Number: All available lots
Product Form: Capsules
Product Description: Dietary supplement for male enhancement
Product Image:
NAFDAC implores members of the public in possession of the above product to stop the sale or use of the product and handover product to the nearest NAFDAC office.
NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety, and efficacy of medicines, medical devices, and other regulated products circulating in Nigeria.
Consumers are also encouraged to report compromised products (medicines or medical devices) to the nearest NAFDAC office, NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Healthcare professionals and patients should 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!!!
