The National Agency for Food and Drug Administration and Control (NAFDAC) has raised alarm over the circulation of a suspected substandard and falsified (SF) antibiotic, BETACLOX, in the Nigerian drug market.

In a public alert, the agency disclosed that the product — a combination of ampicillin and cloxacillin — was discovered to have fraudulent registration details and originates from an unverified source, posing serious risks to public health.

According to NAFDAC, the fake product was first procured from Gambori Market in Maiduguri, Borno State, by a distributor in Kano, who subsequently sold it to a retail outlet in Zaria, Kaduna State. The Zaria retailer, upon suspecting the authenticity of the product, promptly reported it to the agency, triggering an investigation.

Preliminary findings revealed that the NAFDAC Registration Number (A4-4724) displayed on the counterfeit product actually belongs to a different medication — Mebendazole 500mg, manufactured by Chi Ltd. NAFDAC described this as a clear case of registration number misappropriation.

Further investigation into the packaging details exposed additional inconsistencies. While the counterfeit product lists its address as “No. 128 MCC Road, Calabar”, verification with the Pharmacists Council of Nigeria (PCN) confirmed that the genuine Freeview Pharmaceutical Ltd. is located at “No. 101 MCC Road, Calabar, Cross River State.” This discrepancy, the agency noted, raises strong suspicion of the unauthorized use of the company’s identity.

BETACLOX, a fixed-dose antibiotic combining ampicillin and cloxacillin, is commonly used to treat bacterial infections of the respiratory tract, ear, nose, throat, urinary tract, skin, soft tissue, and gastrointestinal system.

Details of the Suspected Product:

• Product Name: BETACLOX (Ampicillin 250mg + Cloxacillin 250mg)
• Alleged Importer: Freeview Pharmaceutical Ltd.
• Address on Pack: No. 128 MCC Road, Calabar, Cross River State
• Manufacturer: Saeny Laboratory Pvt. Ltd., Elappunkal Junction, Kozhuvanal, Kerala, 864 423, India
• Batch No.: 230701
• Manufacturing Date: July 2023
• Expiry Date: July 2026
• NAFDAC Reg. No.: A4-4724

NAFDAC has urged healthcare providers, medicine distributors, and consumers to exercise heightened vigilance and immediately report any suspected cases of substandard or falsified medicines or medical devices to the nearest NAFDAC office.