Nigeria News | NAFDAC Alerts Nigerians on Falsified ICLUSIG Traded Globally

RECALL
Image Credit: NLIPW

The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians of falsified versions of ICLUSIG 15mg and ICLUSIG 45mg circulating in the WHO Region of Europe and the WHO Region of the Americas.

The falsified product was reported to WHO on 15 January 2019, by health authorities in Switzerland that a local wholesaler had purchased packs of ICLUSIG 15mg.

Verification reveals that the products are falsified and that there are two versions of falsified ICLUSIG being traded globally according to the market authorization holder. Laboratory analysis conducted for ICLUSIG 15mg with batch number 25A19E09 confirmed that the product does not contain Ponatinib and instead contains paracetamol while that of ICLUSIG 45mg with batch number PR072875 confirmed that the product does not contain Ponatinib but instead contains paracetamol.

The active pharmaceutical ingredient of the Genuine ICLUSIG is Ponatinib Hydrochloride, which is used to treat different forms of leukaemia.

The details of the two version of falsified ICLUSIG are:

Product NameICLUSIG 45mg (30 tabletsICLUSIG 15mg (60 tablets
Stated manufacturerINCYTE Biosciences UK Ltd.ARIAD Pharma Ltd
Batch NumberPR07287525A19E09
Expiry Date12/201910/2020
Language on packagingEnglishEnglish
Laboratory analysis Does not contain Ponatinib; Paracetamol identified.Does not contain Ponatinib; Paracetamol identified

ICLUSIG is commercialized by different stakeholders in different parts of the world. The pharmaceutical companies TAKEDA and INCYTE are the genuine manufacturers  for ICLUSIG in the regions in which the above falsified versions have been discovered to date and they have both confirmed to WHO that they did not manufacture or supply the above products and that the above batch numbers do not correspond to genuine manufacturing records.

NAFDAC advices wholesaler, distributor, and pharmacies to be vigilant and purchase the product from reliable sources while also imploring health care providers and the general public to notify the nearest NAFDAC office of any information concerning the distribution, sale, and use of the falsified two versions of ICLUSIG products.

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About Nathaniel Adebayo 272 Articles
Nathaniel is a News Reporting Intern at Nigerian Law Intellectual Property Watch (NLIPW). He has a passion for writing, capacity building and social media marketing. He is a graduate of Federal University of Technology, Minna, where he graduated with BTECHAGRIC. He is a member of Soil Science Society of Nigeria (SSSN) and the National Union of Campus Journalist (NUCJ). Nathaniel has served as Editor-in-Chief for a number of magazines and as a contributor to various online repositories. Email: anathaniel@nlipw.com

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