The National Agency for Food and Drug Administration and Control (NAFDAC) has raised an alert over a suspected substandard and falsified (SF) pharmaceutical product identified in Nigeria’s drug supply chain.
The product, BETACLOX (Ampicillin 250mg and Cloxacillin 250mg), was found to contain fraudulent registration details and originated from an unverified source, posing serious public health risks.
The agency’s probe shows that the SF (substandard and falsified) product was procured from Gambori Market in Maiduguri metropolis, Borno State, by a distributor operating in Kano.
The same product was later supplied to a retail outlet in Zaria, Kaduna State, which raised the alarm by reporting the product as suspected SF.
Preliminary investigation by NAFDAC revealed that the registration number printed on the packaging, NAFDAC Registration Number A4‑4724, actually belongs to a different drug: Mebendazole 500mg, manufactured by Chi Ltd. This marks a clear case of misappropriation of a registration number, according to NAFDAC.
Further scrutiny uncovered that the packaging claims the importer to be Freeview Pharmaceutical Ltd. at No. 128 MCC Road, Calabar.
But verification against the Pharmacists Council of Nigeria list of registered premises confirms that Freeview Pharmaceutical Ltd. is actually located at “No. 101 MCC Road, Calabar, Cross River State.” That mismatch deepens the authenticity concerns over the product.
BETACLOX, a fixed‑dose combination of ampicillin and cloxacillin, is used to treat bacterial infections of the respiratory tract, ears, nose and throat, urinary tract, skin and soft tissues, as well as the gastrointestinal system. The presence of a falsified version of this antibiotic poses a major risk: patients could receive ineffective treatment, the disease could persist or worsen, and antimicrobial resistance could be accelerated.
In its alert, NAFDAC stated that the sale of unregistered medicines endangers people’s health, as it fails to meet regulatory standards, which ensure the safety, quality, and efficacy of these products.
(Nairametrics)
