{"id":6337,"date":"2025-06-18T11:56:40","date_gmt":"2025-06-18T11:56:40","guid":{"rendered":"https:\/\/regtechafrica.com\/healthcare\/?p=6337"},"modified":"2025-06-18T11:56:40","modified_gmt":"2025-06-18T11:56:40","slug":"nigeria-nafdac-issues-alert-on-circulation-of-unregistered-tarivid-antibiotic-in-lagos","status":"publish","type":"post","link":"https:\/\/regtechafrica.com\/healthcare\/nigeria-nafdac-issues-alert-on-circulation-of-unregistered-tarivid-antibiotic-in-lagos\/","title":{"rendered":"Nigeria: NAFDAC Issues Alert on Circulation of Unregistered Tarivid Antibiotic in Lagos"},"content":{"rendered":"

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public health alert over the circulation of an unregistered batch of Tarivid 200mg<\/em>\u2014a brand of the antibiotic ofloxacin\u2014in Lagos State.<\/p>\n

In Public Alert No. 021\/2025<\/em> published on its website, the agency disclosed that the unauthorized product was discovered during a routine surveillance operation conducted by officials of the Post Marketing Surveillance (PMS) Directorate in the Onipan area of Shomolu Local Government Area.<\/p>\n

Following its discovery, NAFDAC launched an investigation that revealed the product was not approved for distribution within Nigeria. According to the agency, the implicated batch was originally intended for the Pakistani market.<\/p>\n

\u201cThe unregistered batch identified during the surveillance was confirmed by a representative of the product\u2019s Marketing Authorization Holder, SANOFI, as not intended for the Nigerian market,\u201d the alert stated. \u201cA review by Sanofi\u2019s Anti-Falsified and Illicit Trafficking (AFIT) Central Lab further established that this batch is outside the scope of validly registered products authorized by NAFDAC.\u201d<\/p>\n

Tarivid<\/em> (Ofloxacin 200mg) is a fluoroquinolone antibiotic used to treat a wide range of bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and kidney-related bacterial conditions.<\/p>\n

NAFDAC emphasized that unregistered medicines pose a serious threat to public health, as they have not undergone regulatory scrutiny for quality, safety, and efficacy.<\/p>\n

\u201cThe sale and use of unregistered medical products undermine regulatory controls and expose patients to potential harm due to unknown pharmacological profiles or contamination,\u201d the agency warned.<\/p>\n

Details of the counterfeit product include:<\/h3>\n
    \n
  • \n

    Brand Name:<\/strong> Tarivid (Ofloxacin 200mg)<\/p>\n<\/li>\n

  • \n

    Manufacturer:<\/strong> Sanofi<\/p>\n<\/li>\n

  • \n

    Manufacture Date:<\/strong> September 2023<\/p>\n<\/li>\n

  • \n

    Expiry Date:<\/strong> August 2028<\/p>\n<\/li>\n

  • \n

    Stated National Registration Number (NRN):<\/strong> AL016<\/p>\n<\/li>\n<\/ul>\n

    To mitigate risks, NAFDAC has instructed its zonal directors and state coordinators to intensify surveillance activities and initiate a national mop-up of the affected product.<\/p>\n

    \u201cAll zonal directors and state coordinators have been directed to carry out aggressive market surveillance and remove the unregistered antibiotic from circulation,\u201d the statement said.<\/p>\n

    The agency further called on all supply chain stakeholders\u2014distributors, pharmacists, healthcare professionals, and caregivers\u2014to remain vigilant and ensure that all pharmaceutical products are procured only from authorised, licensed sources.<\/p>\n

    \u201cMedicine distributors and retailers must verify the authenticity of medical products and maintain strict compliance with sourcing protocols. Healthcare providers are advised to scrutinize packaging details and report any anomalies,\u201d NAFDAC advised.<\/p>\n

    In line with pharmacovigilance best practices, the agency urged consumers and medical professionals to report any suspicions regarding substandard or falsified medical products through its nationwide offices or via the electronic reporting platforms available on the NAFDAC website.<\/p>\n

    \u201cAdverse events and suspected product-related side effects should be promptly reported through NAFDAC\u2019s Med Safety App or the e-reporting portals to ensure swift regulatory intervention,\u201d it concluded.<\/p>\n","protected":false},"excerpt":{"rendered":"

    The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public health alert over the circulation of an unregistered batch of Tarivid 200mg\u2014a brand of the…<\/p>\n","protected":false},"author":1,"featured_media":6339,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[90,78],"tags":[],"class_list":["post-6337","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nigeria","category-regulatory"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/regtechafrica.com\/healthcare\/wp-content\/uploads\/2025\/06\/NAFDAC-Issues-Alert-on-Circulation-of-Unregistered-Tarivid-Antibiotic-in-Lagos.jpeg?fit=677%2C354&ssl=1","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/6337","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/comments?post=6337"}],"version-history":[{"count":1,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/6337\/revisions"}],"predecessor-version":[{"id":6338,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/6337\/revisions\/6338"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/media\/6339"}],"wp:attachment":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/media?parent=6337"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/categories?post=6337"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/tags?post=6337"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}