The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a serious public health warning following the discovery of an unauthorized antibiotic, Tarivid 200mg (Ofloxacin), currently being circulated in parts of Lagos State. This alert, marked as Public Alert No. 21/2025, was officially published on the agency’s website after a routine post-marketing surveillance revealed the presence of the product in Onipan, Shomolu Local Government Area.

According to NAFDAC, its Post Marketing Surveillance Directorate detected the suspicious product during a field inspection, prompting an immediate investigation. The findings were alarming: the particular batch of Tarivid was never registered for distribution in Nigeria and had originally been designated for the Pakistani pharmaceutical market.

Batch Confirmed Unauthorized: Sanofi Responds

As the investigation deepened, NAFDAC contacted Sanofi, the multinational pharmaceutical company responsible for manufacturing Tarivid. A representative from Sanofi’s Anti-Falsified and Illicit Trafficking (AFIT) Central Laboratory confirmed that the batch in question had no approval for use in Nigeria. Sanofi further explained that the product was manufactured solely for the Pakistan market and did not fall under any valid NAFDAC registration.

This confirmation immediately escalated the matter, leading NAFDAC to classify the circulation of the product as illicit and potentially dangerous to public health.

Why Tarivid Matters: Understanding the Drug and the Risk

Tarivid is a brand name for Ofloxacin, a powerful fluoroquinolone antibiotic widely prescribed to treat bacterial infections affecting the respiratory system, urinary tract, skin, kidneys, and soft tissues. While the drug plays a crucial role in modern medical treatment, its safety and effectiveness can only be guaranteed when it meets regulatory standards specific to the country where it is sold.

When unauthorized batches like the one discovered in Lagos bypass proper regulatory scrutiny, patients are exposed to serious risks. These include potential ineffectiveness due to improper storage, incorrect dosage formulations, and possible contamination. Furthermore, such unregistered products lack verified safety data, meaning healthcare providers and consumers cannot confidently rely on them for treatment outcomes.

Specific Details of the Affected Product

The compromised batch of Tarivid was manufactured in September 2023 with an expiry date listed as August 2028. It bears the National Registration Number AL016, a detail that falsely implies compliance with NAFDAC standards. However, upon verification, NAFDAC concluded that the number does not correspond to any officially registered medication within its database.

Given this fraudulent labeling, NAFDAC has classified the product as counterfeit, a designation that reflects both its unauthorized presence in Nigeria and its potential to harm public health.

Immediate Actions Taken by NAFDAC to Protect the Public

In response to the situation, NAFDAC wasted no time in implementing corrective measures. The agency has directed all zonal directors and state coordinators across Nigeria to intensify field surveillance and begin an aggressive mop-up operation. This nationwide campaign aims to remove every unit of the counterfeit Tarivid batch from circulation.

NAFDAC also announced that it would increase inspections of pharmacies, medicine vendors, and hospitals to ensure strict compliance with national drug safety regulations.

What Stakeholders Should Do Now

In light of the unfolding situation, NAFDAC is calling on all actors within the pharmaceutical supply chain to take proactive steps. Distributors, wholesalers, retailers, and healthcare professionals must immediately verify the source, labeling, and packaging of all Tarivid 200mg products in their inventory. If any item matches the details of the unapproved batch, it must be withdrawn and reported without delay.

The agency also strongly advised the public to only purchase medicines from authorized, licensed outlets and to exercise heightened caution when buying antibiotics or any other prescription drugs.

How to Report Suspicious Products and Side Effects

To ensure a comprehensive response, NAFDAC has encouraged both healthcare professionals and the general public to report:

• Any suspected substandard or falsified medicines

• Any adverse reactions or side effects experienced after using medicinal products

These reports can be submitted through several official channels:

• By visiting the nearest NAFDAC office

• By using the electronic reporting portal available on the agency’s official website

• Through the NAFDAC Med Safety App, which allows real-time reporting from mobile devices

According to the agency, prompt reporting enables rapid intervention, helping authorities trace distribution points and prevent further public exposure.

The Bigger Picture: A Reminder of the Dangers of Counterfeit Drugs

This case serves as yet another reminder of the dangers posed by counterfeit or unapproved medications circulating within Nigeria’s healthcare system. Beyond undermining trust in the health sector, such products often result in treatment failure, drug resistance, or even death.

NAFDAC reiterated its unwavering commitment to safeguarding public health by intensifying efforts to eliminate unregistered and unsafe pharmaceutical products from the market.

In closing, the agency called on all Nigerians to become active participants in this fight by staying informed, remaining cautious, and reporting any irregularities they encounter.