The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public warning following the discovery of an unregistered batch of Tarivid 200mg, an antibiotic, circulating in Lagos.
EpeInsights reports that NAFDAC in a statement released on Monday via its official website, revealed that the product manufactured by pharmaceutical giant Sanofi was detected during a routine surveillance operation conducted by officers from NAFDAC’s Post-Marketing Surveillance Directorate in the Onipanu area of Shomolu Local Government Area.
According to the agency, further investigations confirmed that the identified batch was not approved for distribution in Nigeria.
Sanofi, the product’s Marketing Authorisation Holder, clarified that the specific batch of Tarivid 200mg was originally intended for the Pakistani market. This was confirmed through an analysis carried out by Sanofi’s Anti-Falsified and Illicit Trafficking (AFIT) Central Laboratory.
NAFDAC emphasized that the batch is not covered by any valid registration in Nigeria and is, therefore, unauthorised for local use.
Tarivid, which contains Ofloxacin, is a broad-spectrum antibiotic used to treat various bacterial infections affecting the respiratory tract, urinary tract, kidneys, skin, and soft tissues.
The agency warned that the presence of unregistered medicines in the Nigerian market poses a serious threat to public health. “The sale of unregistered medicines poses a risk to people’s health, since, by not complying with regulatory provisions, the safety, quality, and efficacy of such products are not guaranteed,” NAFDAC stated.
Details of the unregistered product include: Product Name: Tarivid (Ofloxacin 200mg), Manufacturer: Sanofi, Manufacture Date: September 2023, Expiry Date: August 2028 and Stated Registration Number: AL016 (not authorised by NAFDAC).
In response, NAFDAC has instructed all zonal directors and state coordinators to intensify market surveillance and ensure the immediate removal of the affected product from circulation.
The agency also called on healthcare providers, pharmacists, retailers, and consumers to remain vigilant, urging them to procure medical products only from authorised and licensed suppliers.
“All medical products must be obtained from authorised/licensed suppliers. The products’ authenticity and physical condition should be carefully checked,” the agency advised.
Anyone who suspects the presence of substandard or falsified medicines is encouraged to report to the nearest NAFDAC office or contact the agency.
