The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a nationwide alert banning an unregistered batch of Tarivid (Ofloxacin 200mg), a widely used antibacterial medication manufactured by Sanofi, due to serious public health concerns.
According to Public Alert No. 21/2025, titled “Alert on the Report of Unregistered Tarivid (Ofloxacin 200mg) Found in Nigeria,” the unauthorized batch was discovered during routine surveillance in the Onipan area of Shomolu Local Government Area, Lagos State. Despite bearing a NAFDAC Registration Number (NRN: AL016), the batch—manufactured in September 2023 and set to expire in August 2028—was never approved for the Nigerian market.
Subsequent investigations revealed that the batch was originally intended for distribution in Pakistan and was not authorized for use in Nigeria. Sanofi, the product’s Marketing Authorisation Holder, confirmed this and further validated the information through its Anti-Falsified and Illicit Trafficking (AFIT) Central Laboratory.
NAFDAC warned that the unregistered product does not fall under its regulatory oversight, meaning its safety, quality, and efficacy cannot be guaranteed. The agency emphasized the significant health risks posed by falsified and unregistered medicines and announced that the details of the counterfeit Tarivid batch will be shared with the World Health Organisation’s Global Surveillance and Monitoring System (GSMS) to support international efforts in combating counterfeit pharmaceuticals.
In response, NAFDAC has directed its zonal and state offices to increase surveillance and carry out a mop-up operation to remove the affected batch from circulation. Healthcare professionals, pharmacists, and drug distributors are urged to be vigilant and ensure that all pharmaceutical products are procured only from authorized and licensed suppliers.
The agency also called on the public to report any suspicious medications or adverse drug reactions through its official reporting channels, including electronic platforms available on the NAFDAC website.
Tarivid is a prescription-only broad-spectrum antibiotic used to treat infections of the respiratory tract, urinary tract, kidneys, skin, and soft tissues. NAFDAC reiterated that it should only be used under the supervision of qualified healthcare professionals.
