The National Agency for Food and Drug Administration and Control (NAFDAC) has notified the public regarding the recall of all batches of MR.7 Super 700000 capsules, citing safety concerns linked to undeclared pharmaceutical ingredients.
The agency made the announcement on Monday through a public advisory that was posted on its official website.
As per NAFDAC's statement, the recall was initiated by the manufacturer of the product, StuffbyNainax LLC, following an analysis carried out by the US Food and Drug Administration (FDA), which discovered that the capsules contained undeclared ingredients, specifically sildenafil and tadalafil. These are substances typically used in medications approved for the treatment of erectile dysfunction.
Both substances belong to a category of medications known as phosphodiesterase (PDE-5) inhibitors.
NAFDAC elaborated that the inclusion of these ingredients, not listed on the product's label, categorizes the capsules as unapproved drugs, meaning their safety and effectiveness have not been established.
The product was marketed online as a dietary supplement aimed at enhancing male performance. NAFDAC emphasized that it is inappropriate to sell any supplement that contains sildenafil or tadalafil.
Details of the recalled product indicate that it is the MR.7 Super 700000, manufactured by StuffbyNainax LLC and distributed in capsule form.
The recall encompasses all current batches of this supplement, which was being advertised as a dietary aid for male enhancement.
NAFDAC urged anyone possessing these capsules to cease usage and sales immediately and to return them to the nearest NAFDAC office.
The agency also encouraged the general public and healthcare providers to report any suspected counterfeit or substandard medicines, as well as any adverse effects associated with medicinal products, using its established channels for reporting.
In terms of health risks, NAFDAC cautioned that consuming products containing undeclared sildenafil or tadalafil can lead to significant health issues.
These substances have the potential to interact with nitrates, which are often prescribed for certain heart conditions, such as nitroglycerin. Such interactions can result in a dangerous drop in blood pressure, posing serious risks to individuals.
Patients with diabetes, hypertension, high cholesterol, or heart disease may be particularly susceptible to these effects.
Moreover, adult males who are on nitrate medications for cardiac issues face heightened risks if they take the affected product.
This recall coincides with rising warnings from NAFDAC about the distribution of unsafe and counterfeit medicines in Nigeria.
Recently, the agency has alerted healthcare professionals and the public about the presence of counterfeit Avastin 400 mg vials being circulated in the country, which could pose severe risks for patients relying on it for cancer therapies.
Avastin (Bevacizumab) is utilized in treating recurrent glioblastoma in adults, functioning by obstructing the generation of blood vessels that facilitate tumor growth.
NAFDAC indicated that the initial concern regarding counterfeit Avastin was raised by Roche, the drug's marketing authorization holder, after an oncologist noted dubiousities surrounding the labeling of certain Avastin vials.
The agency reaffirmed its commitment to public health safety and will continue its surveillance efforts to ensure the quality and efficacy of medications and other regulated products available in Nigeria.
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