The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted the public to the recall of all batches of MR.7 Super 700000 capsules due to safety concerns over undeclared pharmaceutical ingredients.
The agency disclosed this on Monday in a public advisory published on its website.
NAFDAC said the recall was initiated by the product’s manufacturer, StuffbyNainax LLC, after the US Food and Drug Administration (FDA) analysed the capsules and found they contain undeclared sildenafil and tadalafil, substances commonly used in medicines approved for the treatment of erectile dysfunction.
According to the agency, both substances belong to a class of medicines known as phosphodiesterase (PDE-5) inhibitors.
It explained that the presence of these ingredients, which were not declared on the product label, renders the capsules unapproved drugs whose safety and efficacy have not been established.
The product, marketed online as a dietary supplement for male enhancement, should not be sold as a supplement if it contains sildenafil or tadalafil, the agency said.
Product details
According to the advisory, the recalled product is MR.7 Super 700000, manufactured by StuffbyNainax LLC and sold in capsule form.
The recall affects all available batches of the product, which is marketed as a dietary supplement intended for male enhancement.
NAFDAC urged members of the public in possession of the capsules to stop using or selling them and to hand them over to the nearest NAFDAC office.
The agency also encouraged consumers and healthcare professionals to report suspected substandard or falsified medicines, as well as any adverse reactions linked to medicinal products, through its reporting channels.
Health risks
NAFDAC warned that consuming products containing undeclared sildenafil or tadalafil may pose serious health risks.
The agency explained that these substances can interact with nitrates commonly found in prescription medicines used to treat certain heart conditions, such as nitroglycerin. Such interactions may lead to a dangerous drop in blood pressure, which can be life-threatening.
Individuals with diabetes, high blood pressure, high cholesterol, or heart disease often use nitrate-based medications and may therefore be particularly vulnerable.
NAFDAC added that adult males taking nitrates for cardiac conditions face the highest risk if they consume the product.
Recent counterfeit drug warning
The recall comes amid renewed warnings by NAFDAC over the circulation of unsafe and falsified medicines in the country.
Recently, the agency alerted healthcare providers and the public to the circulation of counterfeit Avastin 400 mg vials in Nigeria, warning that the falsified medicine could pose serious risks to patients relying on it for cancer treatment.
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Avastin (Bevacizumab) is used to treat recurrent glioblastoma in adults. The medicine works by blocking the formation of blood vessels that supply tumours, thereby slowing their growth.
According to NAFDAC, the suspected counterfeit product was first flagged by the drug’s marketing authorisation holder, Roche, after an oncologist at a local hospital raised concerns about the authenticity of certain Avastin vials labelled 400 mg/16 ml.
The agency said it remains committed to safeguarding public health and will continue surveillance activities to ensure the safety, quality and efficacy of medicines and other regulated products circulating in Nigeria.