The National Agency for Food and Drug Administration and Control (NAFDAC) has warned the public about a suspected falsified (SF) pharmaceutical product, BETACLOX, in Nigeria.
NAFDAC explained that the product (a combination of ampicillin and cloxacillin), bears fraudulent registration details and originates from an unverified source, posing significant risks to public health.
According to the regulatory body, the SF product was procured from Gambori Market in Maiduguri metropolis, Borno State, by a distributor in Kano, who later sold it to a retail outlet in Zaria, Kaduna State.
“The retail outlet in Zaria reported the product as suspected SF, initiating this investigation. Preliminary investigation revealed that the NAFDAC Registration Number (NRN) A4-4724 displayed on the SF product belongs to an entirely different product: Mebendazole 500mg, manufactured by Chi Ltd. This is a clear case of misappropriation of a registration number.
“While the SF product packaging displays the address as ‘No. 128 MCC Road, Calabar’, verification against the PCN (Pharmacists Council of Nigeria) list of registered premises confirms that Freeview Pharmaceutical Ltd. is located at No. 101 MCC Road, Calabar, Cross River State,” NAFDAC said.
It noted that the discrepancy raises additional concerns about the product’s authenticity and the potential unauthorised use of the company’s name.
The agency emphasised that BETACLOX is a combination of ampicillin and cloxacillin, adding that Ampicillin + Cloxacillin Capsules are a fixed-dose combination drug used to treat bacterial infections of the respiratory tract, ear, nose and throat, urinary tract, skin and soft tissue, and gastrointestinal system.
NAFDAC warned that the sale of unregistered medicines endangers public health, as such products fail to meet regulatory standards that ensure their safety, quality, and efficacy.
Details of the Product:
Product Name: BETACLOX (Ampicillin 250mg and Cloxacillin 250mg).
Alleged Importer: Freeview Pharmaceutical Ltd.
Address: No. 128 MCC Road, Calabar, Cross River State.
Manufacturer: Saeny Laboratory Pvt, Ltd, Elappunkal Junction, Kozhuvanal, Kerala, 864 423 India.
Batch No.: 230701
Man. Date: 07/2023
Exp. Date: 07/2026
NAFDAC REG. NO: A4 4724
Product Photos
The regulatory body directed all its zonal directors and state coordinators to carry out surveillance and mop up the SF product — and urged distributors, retailers, healthcare professionals, and caregivers to exercise caution and vigilance within the supply chain to avoid the distribution, sale, and use of the SF product.
It advised that all medical products should be obtained from authorised or licensed suppliers, and that the authenticity and physical condition of such products should be carefully checked.
NAFDAC also urged healthcare professionals and consumers to report any suspicion of the sale of substandard and falsified medicines or medical devices to its nearest office, by calling 08001623322, or via email at sf.alert@nafdac.gov.ng.
It further encouraged healthcare professionals and patients to report adverse events or side effects related to the use of medicinal products or devices to its nearest office, through the use of the E-reporting platforms available on its website www.nafdac.gov.ng, via the Med-safety application available for download on Android and IOS stores, or via e-mail at pharmacovigilance@nafdac.gov.ng.
