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The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public that some suspected falsified Coartem – 20/120mg – green blister packs were found in North Central Zone (Jos in particular). Also, a similar report was received in DR Congo
The stated manufacturer, Novartis, confirmed in October 2021 that it no longer manufactures authentic versions of the green flat blisters that were targeted for falsification. According to Novartis, the last authentic version of these Coartem blisters expired in November 2020.
Therefore, there should be no more authentic versions of this green Novartis Coartem pack in circulation in sub-Saharan Africa.
The products were observed to have the same batch numbers but different manufacturing and expiry dates.
The details of the falsified Coartem tablets found in Jos are as follows.
Product Name: Coartem – 20/120mg tablet
Stated Product Manufacturer: Novartis Pharmaceutical Corporation, Suffam, New York, USA.
Batch No. | Manufacturing date | Expiry date |
F2261 | 09/2019 | 09/2022 |
F2261 | 05/2020 | 05/2023 |
F2261 | 6/2021 | 06/2024 |
The details of the falsified Coartem tablets found in DRC Congo are as follows.
Product Name: Coartem – 20/120mg tablet
Stated Product Manufacturer: Novartis Pharmaceutical Corporation, Suffam, New York, USA.
Batch No. | Manufacturing date | Expiry date |
F2261 | 06/2021 | 06/2024 |
F2261 | 02/2022 | 02/2025 |
F2261 | 05/2020 | 05/2023 |
KAJ44 | 02/2021 | 01/2023 |
Product photos
However, it is likely that these products may have been distributed to other parts of the country through informal markets. It is important to detect and remove them from circulation to prevent harm to patients.
NAFDAC implores importers, distributors, retailers and healthcare providers to always exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and administration or use of falsified or substandard medicinal products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Members of the public in possession of the above-listed products are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
If you have these substandard products, please DO NOT use them. If you, or someone you know, have used these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines 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 the medicinal product 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