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The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public that the Federal Commission for the Protection Against Sanitary Risks (Cofepris) have issued a warning in Mexico against the illegal circulation of counterfeit Tecfidera (Dimethyl Fumarate) 240mg capsules, manufactured by Biogen de México, S. de R.L.
The Commission issued this health alert following the analysis of the information presented by the company Biogen de México, S. de RL de CV, holder of the sanitary registration in Mexico of the product Tecfidera® (dimethyl fumarate) 240mg capsules. The company identified the illegal marketing and distribution of the product with batch number JFLS900, and expiration date 05-2023, intended for distribution in Turkey.
Tecfidera is a medication used to treat relapsing forms of multiple sclerosis in adults.
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: Tecfidera® (dimethyl fumarate) 240mg capsules.
Product Manufacturer : Biogen de México, S. de RL de CV.
Lot Number: JFLS900
Expiry date: 05-2023
Images to identify the illegally marketed product:
Please note that the product is not in NAFDAC database. However, importers, importers, distributors, retailers, healthcare professionals and caregivers are 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 and medical devices must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Members of the public are hereby advised not use any product that displays a language other than English and also check if they have the affected batch in their possession. If so, you are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
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
