28/29 September 2021
Again, the company Orifarm must recall batches because of suspicion of falsification. The company located in Leverkusen, Germany has received information from the Greek Competent Authority according to which blisters with the batch numbers A05673 and A05668 do not correspond to the batch numbers on the package.
Via the Drug Commission of German Pharmacists (Arzneimittelkommission der Deutschen Apotheker) Orifarm has informed pharmacists that they should verify the packages of Cialis 20 mg (Tadalafil) with the batch numbers in question and check whether the blisters have been falsified or not. According to the company, no other batch is affected.
According to the company's own information, Orifarm is one of Germany's leading pharmaceutical importers. This new case raises the question how secure the import of medicinal products is, even if imported medicinal products are subject to the same requirements as all other medicinal products. However, importation is a potential source of counterfeits. Already in the past, the company Orifarm had to recall batches because of counterfeiting. In 2014, the branch service Apotheke Adhoc (in German language) reported about counterfeits at Orifarm. At that time, counterfeits of the cancer treatment Sutent (Sunitinib) came on the market. The falsified drugs came from Romania. Not only Orifarm but also the company CC Pharma was involved.
In 2015, the German Newspaper "Deutsche Apotheker Zeitung" (in German language) reported about a further case: a batch of the antiplatelet drug Aggrenox® (acetylsalicyl acid, dipyridamole), the anticoagulant Clexane® 40 mg (enoxaparin) and the atypical neuroleptic Seroquel Prolong® 300 mg (quetiapine) was affected. Just recently, the Higher Regional Court for the Land of North Rhine-Westphalia in Germany (Oberverwaltungsgericht Nordrhein-Westfalen) has decided a case involving the company Orifarm. Orifarm wanted to obtain that batches of medicinal products from Romania which had left the legal supply chain could be released again on the market. The Court stated that the EU GDP Guidelines leave no room for manoeuvre - especially against the background of potential counterfeiting activities or because of the potential impact on the product quality. The batches could not be released again. Read more in our News from 31 March 2016 "Court Judgement: A Medical Product can not be Marketed Anymore if it has Left the Legal Supply Chain".