NAFDAC Issues Warning Over Suspected Substandard and Falsified Antibiotic
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning to Nigerians about the circulation of a suspected substandard and falsified antibiotic known as BETACLOX, which contains ampicillin 250mg and cloxacillin 250mg. According to a statement released on the agency’s X account, the product has fraudulent registration details and originates from an unverified source, posing a serious threat to public health.
The alert came after a retail outlet in Zaria, Kaduna State, identified the suspicious product following its purchase from a distributor in Kano. The investigation revealed that the NAFDAC Registration Number (A4-4724) displayed on the fake BETACLOX package actually belongs to Mebendazole 500mg, manufactured by Chi Ltd. This indicates a clear case of misappropriation of a registration number.
The fake product is allegedly imported by Freeview Pharmaceutical Ltd., which lists its address as No. 128 MCC Road, Calabar, Cross River State. However, verification by NAFDAC confirmed that the genuine Freeview Pharmaceutical Ltd. is registered at No. 101 MCC Road, Calabar, further exposing inconsistencies that suggest the unauthorized use of the company’s identity.
Key Details About the Suspected Product
The SF product was reportedly procured from Gambori Market in Maiduguri metropolis, Borno State, by a distributor in Kano who then sold it to a retail outlet in Zaria, Kaduna State. The retail outlet reported the product as suspected substandard and falsified, which led to the investigation.
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.
Information About BETACLOX
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.
Product Details:
- 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
Public Health Concerns
The presence of such substandard and falsified pharmaceutical products in the market poses significant risks to public health. These products may not meet the required quality standards, leading to ineffective treatment or even harm to patients. NAFDAC urges the public to remain vigilant and report any suspicious products to the relevant authorities.
Consumers are advised to purchase medications only from licensed pharmacies and to verify the authenticity of the products before use. It is also recommended to check the NAFDAC registration numbers and cross-reference them with the official database to ensure legitimacy.
Steps to Take
If you come across any suspicious pharmaceutical products, take the following steps:
- Report the incident to NAFDAC immediately.
- Avoid using the product until it has been verified as safe.
- Share information with local health authorities or community groups to raise awareness.
- Check the product’s registration number against the NAFDAC database for confirmation.
By staying informed and proactive, the public can play a crucial role in safeguarding their health and the health of others.