Source: Guardian Nigeria
Batch Intended for Pakistan Illegally Circulating in Nigeria, Agency Warns
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued an urgent public health warning, banning an unregistered batch of Tarivid (Ofloxacin 200mg), a broad-spectrum antibiotic manufactured by Sanofi, over serious safety and regulatory concerns.
Unauthorised Batch Detected in Lagos
The flagged batch was discovered during a routine surveillance exercise in Onipan, Shomolu LGA, Lagos State, and was found carrying NAFDAC Registration Number AL016, with a manufacture date of September 2023 and an expiry date of August 2028.
Upon investigation, NAFDAC confirmed that this specific batch was not authorized for the Nigerian market and had originally been manufactured for distribution in Pakistan.
Sanofi and WHO Notified
Sanofi, the Marketing Authorisation Holder for Tarivid, confirmed the batch’s ineligibility for Nigerian circulation. Verification was carried out through Sanofi’s Anti-Falsified and Illicit Trafficking (AFIT) Central Laboratory, which validated that the product was never intended for Nigeria.
“The batch in question falls outside the regulatory oversight of NAFDAC. Therefore, the agency cannot guarantee its safety, quality, or efficacy,” the alert read.
The agency plans to upload the batch details to the World Health Organization’s Global Surveillance and Monitoring System (GSMS) to support global efforts in monitoring counterfeit and misallocated medicines.
Nationwide Mop-Up and Enhanced Surveillance
NAFDAC has instructed zonal directors and state coordinators to initiate mop-up operations aimed at eliminating the batch from circulation and has called on healthcare providers to verify drug sources strictly through authorised channels.
“The circulation and use of unregistered pharmaceutical products pose serious health risks,” NAFDAC emphasized.
The public is urged to report suspicious medicines or adverse drug reactions to the nearest NAFDAC office or through its electronic reporting platform on the agency’s website.
What Is Tarivid?
Tarivid (Ofloxacin 200mg) is a prescription-only antibiotic used in the treatment of:
- Respiratory tract infections
- Urinary tract and kidney infections
- Skin and soft tissue infections
The drug must be administered strictly under medical supervision due to potential side effects and contraindications.
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