The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert over the circulation of a suspected substandard and falsified pharmaceutical product, BETACLOX (Ampicillin 250mg and Cloxacillin 250mg), discovered in Nigeria’s drug supply chain.
According to the agency, the product was found to contain fake registration details and originated from an unverified source, posing serious risks to public health. Investigations revealed that the falsified drug was procured from Gambori Market in Maiduguri, Borno State, by a distributor based in Kano, and later supplied to a retail outlet in Zaria, Kaduna State, where it was flagged as suspicious.
Preliminary findings show that the NAFDAC registration number printed on the packaging, A4-4724, actually belongs to a different product—Mebendazole 500mg manufactured by Chi Ltd., confirming a clear case of registration number misappropriation. The packaging also falsely lists Freeview Pharmaceutical Ltd. as the importer, claiming an address at “No. 128 MCC Road, Calabar.” However, verification with the Pharmacists Council of Nigeria shows the company’s correct address is “No. 101 MCC Road, Calabar,” further casting doubt on the product’s authenticity.
BETACLOX, a fixed-dose combination of ampicillin and cloxacillin, is commonly prescribed to treat bacterial infections affecting the respiratory tract, urinary tract, skin, and gastrointestinal system. NAFDAC warned that the use of a falsified version could result in ineffective treatment, prolonged illness, and contribute to the growing problem of antimicrobial resistance.
The agency emphasized that the sale and use of unregistered medicines threaten public safety because they do not meet regulatory standards guaranteeing product quality, safety, and efficacy.
Product details released by NAFDAC include: Product Name: BETACLOX (Ampicillin 250mg and Cloxacillin 250mg) Alleged Importer: Freeview Pharmaceutical Ltd Address on pack: No. 128 MCC Road, Calabar, Cross River State Manufacturer: Saeny Laboratory Pvt. Ltd., Kerala, India Batch No.: 230701 Mfg. Date: 07/2023 | Exp. Date: 07/2026 NAFDAC Reg. No.: A4-4724
This latest discovery adds to several similar alerts recently issued by NAFDAC about falsified medicines in circulation. These include counterfeit versions of Postinor-2 emergency contraceptive pills, Chloroquine Phosphate tablets with no active ingredient, and Trastuzumab (Herceptin® 600 mg/5 ml) used for breast cancer treatment, all of which were found with fake registration details.
NAFDAC urged distributors, pharmacies, and consumers to remain vigilant, verify product authenticity, and immediately report any suspected counterfeit drugs to the nearest NAFDAC office. The agency reaffirmed its commitment to safeguarding public health and ensuring that only safe, effective, and quality medicines are available in the Nigerian market.
