The National Agency for Food and Drugs Administration and Control has alerted the public to the discovery of an unregistered batch of Tarivid 200mg in Nigeria.
According to a statement released on Monday on the agency’s website, the product, manufactured by Sanofi, was discovered by officers from NAFDAC’s Post-Marketing Surveillance Directorate during a routine surveillance activity in the Onipanu area of Shomolu Local Government Area, Lagos State.
Following the discovery, NAFDAC conducted an investigation which revealed that the identified batch was not intended for the Nigerian market.
A representative of Sanofi, the product’s Marketing Authorisation Holder, confirmed that the batch of Tarivid 200mg was meant for the Pakistani market.
“This conclusion is based on a review conducted on the batch by Sanofi’s Anti-Falsified and Illicit Trafficking (AFIT) Central Laboratory,” the agency said.
NAFDAC noted that the batch in question is not authorised for distribution in Nigeria and does not fall under the scope of a validly registered product with the agency.
Tarivid is a brand of Ofloxacin, an antibacterial agent used for the treatment of bacterial infections in many parts of the body, including the respiratory tract, kidneys, skin, soft tissue, and urinary tract, the statement reads.
The agency warned that the sale of unregistered medicines poses a serious risk to public health.
“The sale of unregistered medicines poses a risk to people’s health, since, by not complying with regulatory provisions, the safety, quality, and efficacy of such products are not guaranteed,” NAFDAC said.
The product details show the name Tarivid (Ofloxacin 200mg), manufactured by Sanofi in September 2023, with an expiry date of August 2028 and a stated National Registration Number of AL016.
NAFDAC has directed all zonal directors and state coordinators to carry out surveillance and remove the affected product from circulation.
The agency further urged distributors, retailers, healthcare professionals, and caregivers to exercise caution and vigilance within the supply chain to prevent the distribution, sale, or use of the product.
“All medical products must be obtained from authorised/licensed suppliers. The products’ authenticity and physical condition should be carefully checked,” NAFDAC said.
Consumers and healthcare professionals are encouraged to report any suspicion of substandard or falsified medicines to the nearest NAFDAC office by calling 0800-162-3322 or emailing sf.alert@nafdac.gov.ng.
