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Public Alert No. 027/2020-Distribution and Sale of Unregistered Daonil 5mg Tablets

November 10, 2020,

The National Agency for Food and Drug Administration and Control has been informed by Sanofi-Adventis Nigeria Limited on the distribution and sale of unregistered Daonil 5mg tablets (60×10) in Nigeria.

Sanofi Adventis Nigeria is the marketing authorization holder for Daonil 5mg tablets (10×10) in Nigeria with NAFDAC registration number (NRN) 04-0744.

The details of the unregistered Daonil 5mg tablets (60×10) is as shown below;                                                                                             

Product Name Daonil 5mg 600 tablets
Stated Product Manufacturer SANOFI
Batch Number 2911220
Manufacturing date May 2018
Expiry date May 2021
Declared Active ingredient Glibenclamide tablets I. P

Daonil (glibenclamide) is used to control blood glucose levels in patients with type 2 diabetes mellitus.

NAFDAC advices wholesalers, distributors, pharmacies and consumers to ensure that products are obtained from authentic and reliable sources. Increased vigilance is hereby encouraged within the supply chain to avoid infiltration of the unregistered Daonil 5mg tablets.

NAFDAC implores healthcare providers to ensure vigilance to prevent the administration of the product to unsuspecting patient.

Health care providers and the general public should notify the nearest NAFDAC office of any information concerning the distribution, sale, and use of the unregistered Daonil 5mg tablets.

Anybody in possession of the unregistered product should immediately discontinue sale or use and submit stock to the nearest NAFDAC office.

Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng  

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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