NAFDAC Bans Unregistered Batch of Tarivid Antibiotic Over Safety Concerns

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The DG of NAFDAC, Mojisola Adeyeye.
The DG of NAFDAC, Mojisola Adeyeye. Photo source: MRCT
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Summary

NAFDAC has banned an unregistered batch of the antibiotic Tarivid (Ofloxacin 200mg), originally meant for the Pakistani market, after it was discovered circulating in Lagos. The agency warned that the product's safety and efficacy cannot be guaranteed and urged healthcare providers to source medicines only through authorised channels.

The National Agency for Food and Drug Administration and Control (NAFDAC) has banned an unregistered batch of the antibacterial drug Tarivid (Ofloxacin 200mg), citing serious safety concerns after circulating in Nigeria’s healthcare supply chain.

Tarivid (Ofloxacin) is a broad-spectrum antibiotic used to treat various bacterial infections, including those affecting the respiratory tract, urinary tract, kidneys, skin, and soft tissues. It is a prescription-only drug and should be used under strict medical supervision.

In a public alert, NAFDAC revealed that the batch, manufactured by global pharmaceutical company Sanofi, was detected during a routine surveillance operation in the Onipan area of Shomolu LGA, Lagos State. Labelled with NAFDAC Registration Number AL016, the batch carried a manufacture date of September 2023 and an expiry date of August 2028.

Investigations also confirmed that the batch was not approved for the Nigerian market and was originally intended for distribution in Pakistan, as verified by Sanofi and its Anti-Falsified and Illicit Trafficking (AFIT) Central Lab. NAFDAC stated that because the product falls outside its regulatory oversight, it cannot guarantee its safety, quality, or efficacy.

The agency warned that using unregistered medicines poses serious health risks and urged healthcare providers, pharmacists, and distributors to verify that all drugs are sourced from licensed and authorised suppliers.

NAFDAC has ordered its zonal directors and state coordinators to begin mop-up operations and intensify surveillance efforts nationwide to prevent further circulation. The batch information will also be uploaded to the World Health Organisation’s Global Surveillance and Monitoring System (GSMS) to support international monitoring of counterfeit products.

NAFDAC called on the public and health professionals to report any suspicious medicines or adverse drug reactions to the nearest NAFDAC office or through its official website and reporting channels.

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