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.
Registration number misappropriated
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.
About BETACLOX
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.
Product details released by NAFDAC
- 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., Elappunkal Junction, Kozhuvanal, Kerala, India
- Batch No.: 230701
- Manufacturing Date: 07/2023
- Expiry Date: 07/2026
- NAFDAC Reg. No.: A4-4724
What you should know
NAFDAC has repeatedly raised alerts about pharmaceutical and health-product risks tied to falsified or substandard drugs circulating in Nigeria. The agency warned about a falsified version of Postinor‑2 (levonorgestrel 0.75 mg) emergency contraceptive pill, noting that counterfeit versions carried batch numbers T36184B and 332 and bore the registration number 04-6985, though they were not imported by the legitimate marketing authorisation holder.
Also highlighted was a falsified version of Chloroquine Phosphate tablets discovered in Jos, which contained no active pharmaceutical ingredient (API) despite showing registration number 04-8769, which turned out to be invalid.
Another alert covered a counterfeit of Trastuzumab (brand name Herceptin® 600 mg/5 ml) used for HER2-positive breast cancer, identified in Ghana and traced back to Nigeria; the batch number was A8519 and did not match any authentic batches from the original manufacturer.
These cases highlight major risks, including patients receiving ineffective or harmful medicines, treatment failures that can lead to complications or death, and threats to the integrity of the pharmaceutical supply chain due to illegal imports, unverified suppliers, and mislabeling.
