The National Agency for Food and Drug Administration and Control (NAFDAC) has banned an unregistered batch of Tarivid (Ofloxacin 200mg), a widely used antibacterial medication, after it was discovered circulating within Nigeria’s healthcare supply chain.
The agency stated that the alert will be uploaded to the World Health Organization (WHO) Global Surveillance and Monitoring System (GSMS) to support international tracking of the counterfeit batch.
In its public alert numbered 21/2025, titled ‘Alert on the Report of Unregistered Tarivid (Ofloxacin 200mg) found in Nigeria’ and released on Tuesday, June 10, 2025, the agency disclosed that the banned product was found on the shelf during a routine surveillance operation in the Onipan area of Shomolu Local Government Area, Lagos State.
Tarivid, manufactured by global pharmaceutical company Sanofi, is a brand of Ofloxacin, a broad-spectrum antibacterial agent used in the treatment of various infections including those of the respiratory tract, urinary tract, kidneys, skin, and soft tissues.
The unregistered product is identified as Tarivid (Ofloxacin 200mg), manufactured by Sanofi, with a manufacturing date of September 2023 and an expiry date of August 2028.
The stated NAFDAC Registration Number (NRN) on the product is AL016.
According to the alert, NAFDAC’s Post-Marketing Surveillance Directorate made the discovery during a market monitoring exercise.
Following this, the agency’s investigation confirmed that the product batch in question was never intended for the Nigerian market.
According to the agency, a representative of Sanofi, the product’s Marketing Authorization Holder, clarified that the identified batch was originally manufactured for distribution in Pakistan.
It said the conclusion was backed by a review conducted at Sanofi’s Anti-Falsified and Illicit Trafficking (AFIT) Central Laboratory.
The batch, according to NAFDAC, falls outside the scope of products registered and approved for circulation in Nigeria.
The agency stated that by not complying with regulatory provisions, the safety, quality, and efficacy of such products are not guaranteed.
NAFDAC warned that the distribution and sale of unregistered medical products such as this pose significant health risks.
In response to the discovery, NAFDAC has directed all zonal directors and state coordinators to intensify surveillance and conduct a mop-up operation to remove the counterfeit batch from circulation across the country.
Distributors, retailers, healthcare professionals, and caregivers have been urged to exercise extreme caution and maintain vigilance across the pharmaceutical supply chain.
The agency emphasized the importance of sourcing medicines from authorized and licensed suppliers and conducting proper verification of product authenticity and physical condition.
NAFDAC is encouraging healthcare professionals and the public to report any suspected cases of substandard or falsified medicines to the nearest NAFDAC office.
In addition, it said adverse reactions or side effects linked to medical products can be reported through the e-reporting platforms on the NAFDAC website.
Credit: THE NATION
