NAFDAC Bans Unregistered Tarivid Batch Over Safety Risks

The National Agency for Food and Drug Administration and Control (NAFDAC) has banned an unregistered batch of the antibiotic Tarivid (Ofloxacin 200mg) due to serious safety concerns.

According to a public alert issued on Wednesday, the affected batch—bearing NAFDAC Registration Number AL016—was discovered during routine surveillance in the Onipan area of Shomolu Local Government, Lagos State. It was found to have been manufactured in September 2023 with an expiry date of August 2028.

NAFDAC revealed that the product, manufactured by global pharmaceutical company Sanofi, was intended for the Pakistani market and had not been approved for use in Nigeria. Sanofi confirmed the batch was not authorized for local distribution and verified its intended destination through its Anti-Falsified and Illicit Trafficking (AFIT) Central Laboratory.

“This batch falls outside NAFDAC’s regulatory oversight, and as such, its safety, quality, and efficacy cannot be guaranteed,” the agency stated.

NAFDAC emphasized that using unregistered medicines poses significant health risks and urged healthcare providers and drug distributors to ensure they only source medicines from licensed suppliers.

In response, the agency has launched a nationwide surveillance and mop-up operation to remove the affected products from circulation. It also plans to upload the batch details to the World Health Organisation’s Global Surveillance and Monitoring System (GSMS) to aid international efforts against counterfeit drugs.

Members of the public and healthcare professionals are encouraged to report any suspicious drugs or adverse reactions to NAFDAC offices or through the agency’s online reporting platforms.

Tarivid is a broad-spectrum antibiotic used to treat infections of the respiratory and urinary tracts, kidneys, skin, and soft tissues. It is a prescription-only drug that should be used under medical supervision.

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