NAFDAC Bans Unregistered Anti-Bacterial Drug Tarivid Over Safety Concerns

Posted by Samuel on Wed 11th Jun, 2025 - tori.ng

The affected batch was found circulating in Nigeria’s healthcare supply chain, sparking serious concerns about public safety.

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert banning an unregistered batch of Tarivid (Ofloxacin 200mg), a widely used antibacterial drug produced by global pharmaceutical company Sanofi.

The affected batch was found circulating in Nigeria’s healthcare supply chain, sparking serious concerns about public safety.

In its official statement — Public Alert No. 21/2025, titled “Alert on the Report of Unregistered Tarivid (Ofloxacin 200mg) found in Nigeria” — NAFDAC disclosed that the counterfeit medication was discovered during a routine surveillance exercise in the Onipan area of Shomolu Local Government Area, Lagos State.

The agency confirmed that the product bore the NAFDAC Registration Number (NRN): AL016, with a manufacture date of September 2023 and expiry date of August 2028. 

However, a follow-up investigation revealed that the batch in question was never approved for distribution within Nigeria and was originally manufactured for the Pakistani market.

To support international efforts in tracking counterfeit medical products, NAFDAC announced that details of the unregistered Tarivid batch would be uploaded to the World Health Organisation’s (WHO) Global Surveillance and Monitoring System (GSMS). This global alert is part of the agency’s coordinated response to curbing the spread of falsified medicines.

A Sanofi representative, acting as the product’s Marketing Authorisation Holder, confirmed to NAFDAC that the specific batch was not authorized for the Nigerian market. Further validation was carried out by Sanofi’s Anti-Falsified and Illicit Trafficking (AFIT) Central Laboratory, which corroborated the batch’s intended distribution for Pakistan only.

NAFDAC emphasised that the batch falls outside the regulatory framework for approved medicines in Nigeria, meaning its safety, quality, and efficacy cannot be guaranteed. 

The agency warned that the sale and use of such unregistered products pose significant health risks to the population.

In response to the discovery, NAFDAC has directed its zonal directors and state coordinators nationwide to intensify surveillance and conduct a mop-up operation to remove the falsified Tarivid batch from circulation.

Healthcare providers, pharmacists, distributors, and retailers have been strongly urged to exercise extreme caution and ensure that all medicines are sourced from authorised and licensed suppliers. 

Proper verification of packaging, authenticity, and physical condition of medicines is now more critical than ever.

NAFDAC is calling on the public and healthcare professionals to report any suspicious or substandard medications to the nearest NAFDAC office or through its electronic reporting platforms available on the agency’s website. 

Reports of adverse drug reactions or side effects are also welcome and critical in ensuring public health safety.

Tarivid is a widely used broad-spectrum antibacterial drug, effective in treating infections of the respiratory tract, urinary tract, kidneys, skin, and soft tissues. 

It is a prescription-only medicine and should only be used under professional medical guidance.

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