The National Agency for Food and Drug Administration and Control (NAFDAC) has banned an unregistered batch of the antibacterial drug Tarivid (Ofloxacin 200mg), citing serious safety concerns after the product was discovered circulating within Nigeria’s healthcare supply chain.

In a public alert issued Wednesday, NAFDAC said the affected batch of Tarivid, manufactured by global pharmaceutical company Sanofi, was detected during a routine surveillance exercise in the Onipan area of Shomolu Local Government Area, Lagos State. The batch carried NAFDAC Registration Number AL016, with a stated manufacture date of September 2023 and expiry date of August 2028.

NAFDAC stated that further investigation revealed the product had not been approved for the Nigerian market and was originally manufactured for distribution in Pakistan.

The agency confirmed that Sanofi, acting as the Marketing Authorisation Holder for Tarivid, verified that the specific batch was not cleared for sale in Nigeria. Additional authentication was carried out by Sanofi’s Anti-Falsified and Illicit Trafficking (AFIT) Central Laboratory, which confirmed the product’s intended market was Pakistan.

“The batch in question falls outside the regulatory oversight of NAFDAC. Therefore, the agency cannot guarantee its safety, quality, or efficacy,” the statement read.

NAFDAC warned that the circulation and use of unregistered pharmaceutical products pose serious health risks, urging healthcare providers and distributors to ensure that all medications are sourced from authorised and licensed channels.

As part of its response, the agency has directed all zonal directors and state coordinators across the country to intensify surveillance and begin a mop-up operation to remove the affected batch from circulation.

NAFDAC said it would upload the batch information to the World Health Organisation’s Global Surveillance and Monitoring System (GSMS) to support international efforts in tracking counterfeit medical products.

The agency also called on the public and healthcare professionals to report suspicious medicines or adverse drug reactions to the nearest NAFDAC office or via its electronic reporting systems available on its website.

Tarivid is a broad-spectrum antibiotic used in the treatment of infections affecting the respiratory tract, urinary tract, kidneys, skin, and soft tissues. It is a prescription-only medicine and should be used strictly under medical supervision.