PositiveNaija Public Alert 41: The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public about a suspected substandard and falsified (SF) pharmaceutical product identified within the drug supply chain. The product in question, BETACLOX (a combination of ampicillin and cloxacillin), contains fraudulent registration details and comes from an unverified source, posing significant risks to public health.
The SF product was procured from Gambori Market in Maiduguri metropolis, Borno State, by a distributor in Kano who subsequently 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.” This discrepancy raises additional concerns about the product’s authenticity and the potential unauthorized use of the company’s name.
BETACLOX is a combination of ampicillin and cloxacillin. 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.
Risk Statement
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.
The details of the SF product are as follows.
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
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the SF product within the zones and states.
Distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the distribution, sale, and use of the SF product. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to 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
PositiveNaija Public Alert
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