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(Last Updated On: September 1, 2023)

Public Alert No. 025/2023 – Presence of Suspected Counterfeit Artequin 600/750 Tablets in Circulation in Nigeria

September 1, 2023,

The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public of a circulation of counterfeit Artequin 600/750 (Artesunate + Mefloquin) tablets in Nigeria. The product is stated to be manufactured by Acino Pharma AG.

The Agency is issuing this alert following the notification received from Occulus PharmaCare Ltd on the behalf of Acino Pharma AG, Switzerland disclosing the distribution of the counterfeit Artequin 600/750 tablets in Onitsha. On investigation, the product was also discovered in Kaduna.

Artequin-600/750 is used to treat patients who present an acute uncomplicated malaria infection caused by Plasmodium falciparum. It is also recommended to treat falciparum malaria parasite which are resistant to other anti-malaria drugs, or malaria caused by mixed malaria parasite.

Risk Statement

The illegal marketing of medicines or counterfeit medicines poses a risk to the health of people, since by not complying with the legal importation, the safety, quality and efficacy of the products are not guaranteed.

Product details

The details of the product are as follows;

Product Name: Artequine-600/750 tablet

Stated Product Manufacturer: Acino Pharma AG

Lot Number: E1702201

Manufacturing date: 12.2023

Expiry date: 11.2025

This product is no longer registered by NAFDAC for use in Nigeria. The product license expired on the 11th of September, 2023, it was formally withdrawn among seven other products from the Nigerian market by Occulus PharmaCare Ltd on the 4th of October, 2022 and should therefore not be found within the country.

Importers, distributors, retailers, healthcare professionals and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the counterfeit product. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng

Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng

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

Signed Management

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