The National Agency for Food and Drug Administration and Control (NAFDAC) has banned an unregistered batch of the widely used antibacterial drug, Tarivid (Ofloxacin 200mg), after uncovering its circulation in Nigeria’s pharmaceutical market.
The regulatory body, in a public notice numbered 21/2025 and titled “Alert on the Report of Unregistered Tarivid (Ofloxacin 200mg) found in Nigeria,” revealed that the counterfeit batch was discovered during a routine surveillance exercise in Onipan, Shomolu Local Government Area of Lagos State.
The medicine, produced by global pharmaceutical giant Sanofi, is known for treating a variety of infections such as those affecting the respiratory tract, urinary tract, skin, soft tissues, and kidneys. However, the particular batch found was confirmed to be unregistered and unauthorized for distribution within Nigeria.
According to NAFDAC, the product was labelled as Tarivid (Ofloxacin 200mg) and carried a manufacturing date of September 2023 with an expiry date of August 2028. It bore the NAFDAC Registration Number (NRN) AL016.
NAFDAC’s Post-Marketing Surveillance Directorate made the discovery during market monitoring activities. Investigations that followed confirmed that the batch was not approved for the Nigerian market.
The agency disclosed that a Sanofi representative, who also serves as the Marketing Authorization Holder for Tarivid in Nigeria, clarified that the batch in question had originally been manufactured for Pakistan, not for Nigeria.
This assertion was further supported by laboratory analysis carried out at Sanofi’s Anti-Falsified and Illicit Trafficking (AFIT) Central Laboratory, which confirmed the product fell outside the scope of what was authorized for local distribution.
The agency stated that “by not complying with regulatory provisions, the safety, quality, and efficacy of such products are not guaranteed.”
In line with standard protocol, NAFDAC has uploaded the alert to the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS) to assist international efforts in tracking and eliminating counterfeit medicines.
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Reacting to the health threat posed by such products, NAFDAC emphasized the grave danger that unregistered drugs present. “The distribution and sale of unregistered medical products such as this pose significant health risks,” the agency warned.
To curb the spread, the agency has instructed all zonal directors and state coordinators to intensify surveillance and launch a nationwide mop-up operation aimed at removing the affected batch from circulation.
Distributors, retailers, health practitioners, and caregivers have been strongly advised to maintain strict vigilance and source medicines solely from authorized, licensed vendors. They are also encouraged to verify the authenticity and physical condition of pharmaceutical products before purchase or administration.
NAFDAC further urged Nigerians to report any suspicious drug products to the nearest NAFDAC office. Adverse drug reactions or side effects linked to any medical product can also be reported through the agency’s e-reporting platform available on the NAFDAC website.
The agency reiterated its commitment to safeguarding public health and ensuring that only safe, effective, and quality-assured medical products circulate within Nigeria’s borders.
