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Public Alert 0031/2022 – Falsified Soliris identified in WHO regions of the Americas, Europe, and Southeast Asia

May 26, 2022,

The National Agency for Food and Drug Administration and Control is notifying Healthcare Providers that Mexico`s Federal Commission for the Protection against Health Risks (Cofepris) reported that the drug Soliris (eculizumab), with lots 1001381, 1012401, 1013715, 1001600 and 1001701 was allegedly counterfeited.

According to the Commission, this was after the collection of information provided by the World Health Organization (WHO) Substandard and Counterfeit Quality Medical Products Surveillance and Tracking System, and health complaints made to the Federal Commission for Protection against Health Risks (Cofepris).

Falsified Soliris have been identified in WHO regions of the Americas, Europe, and Southeast Asia Alert Summary. The Medical Product Alert refers to several batches of falsified Soliris (eculizumab) identified in Argentina, Estonia, India, and Uruguay and reported to WHO between November and December 2021.

According to WHO, the genuine manufacturer of Soliris, has confirmed that the products listed in this alert are falsified. The falsified products were reported at patient level and regulated supply chains in the above-mentioned countries.

Genuine Soliris is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized Myasthenia Gravis (gMG) in adults, and neuromyelitis optica spectrum disorder (NMOSD).

The products identified in this Alert are confirmed as falsified on the basis that they deliberately/fraudulently misrepresent their identity, composition, or source.

Brand Name ExpiryDate Manufacturer Lot No Packaging Language Identified
Soliris (Eculizumab) 300mg SEP/2022 Alexion Pharma International Operations Unlimited Company.

 

1012401 Spanish Argentina

Uruguay

FEB 2022 1013715 Spanish Uruguay
03/2023 1001600 English Estonia
03/2023 1001701 Turkish India

Recommendation

All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional in case of doubt. If you are in possession of the above falsified products, please do not use them.

If you have used these products, or you suffered an adverse reaction/event having used these products, you are advised to seek immediate medical advice from a qualified healthcare professional, and to report the incident to the National Regulatory Authorities/National Pharmacovigilance Centre.

Anyone in possession of the recalled product should qquarantine all remaining stock and return it to your supplier or submit to the nearest NAFDAC.

Healthcare professionals and Hospitals professionals and consumers are advised to report adverse events and quality problems they experience with the use of any medical devices to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via med Safety Application available for download on Android and IOS stores.    

References

https://cdn.who.int/media/docs/default-source/substandard-and-falsified/

https://www.infobae.com/en/2022/03/29/cofepris-warned-about-the-falsification-of-haematological drug.

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

Signed Management

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