Counterfeit packs of the schizophrenia medicine Xeplion 150 mg

25 July 2017, Updated 27 July 2017

One German and several Danish parallel importers and the Danish Medicines Agency have withdrawn several batches of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batches contained counterfeit packs.

Xeplion 150 mg is a medicine for injection used for the treatment of schizophrenia in adults. The medicinal product is available in hospitals or dispensed on prescription at a pharmacy, and the intention is that the patient is injected by a doctor.

On the basis of the available data, the Danish Medicines Agency assesses that the patient risk is low, because an analysis of the counterfeit packs showed that they contained the correct active substance in the appropriate quantities. This means that even if a patient was treated with one of the counterfeit packs, the Danish Medicines Agency does not expect, based on the available information, that the patient has been put in danger or has received inferior treatment.

The parallel importers and the Danish Medicines Agency have cooperated on the withdrawal of the relevant batches from wholesale distributors, hospitals and pharmacies. All other batches, in which a risk of falsification has been identified, have been placed under quarantine and are no longer marketed. They will be released from quarantine when it has been established that they are not falsified.

About the case

This case started in Germany where parallel importer Haemato Pharm found counterfeit packs in a batch of Xeplion 150 mg. At present, we know that at least three batches of Xeplion 150 mg contain both authentic packs and a still unknown number of counterfeit packs. The Danish parallel importers Abacus Medicine, Paranova Danmark, EuroPharmaDK, Orifarm and the German parallel importer Haemato Pharm have repacked packs from the batches that contain falsified products, and several of the parallel importers can confirm that they have counterfeit packs in stock.

At the request of the Danish Medicines Agency, the Danish regions are now sending information to psychiatrists and general practitioners about how they can check whether a pack of Xeplion 150 mg is falsified and about possible alternative products. Other strengths of Xeplion are available and another product with the same active substance is also available on the market. Consequently, supply problems are not expected even though batches of Xeplion 150 mg are withdrawn and placed under quarantine.

The specific findings

The manufacturer of the medicinal product Xeplion 150 mg, Janssen based in Belgium, has examined one of the counterfeit packs from the two affected original batches that were originally manufactured for the Bulgarian and Romanian markets. The examination showed that the counterfeit packs differ from the original packs in a number of ways, including the shade of the colour blue on the pack. The outer packaging is apparently older than the original while the inner packaging is of a more recent date and contains needles with a different expiry date.

Janssen also analysed the contents of a pre-filled syringe in a counterfeit pack. The analysis showed that the syringe contained the correct active substance in the appropriate quantities. However, it cannot be ruled out that the packs have been stored improperly since they were packed outside the legal chain, which by definition makes medicinal products counterfeit.

The Danish Medicines Agency will cooperate with the parallel importers, the authorities in other countries and the European Medicines Agency (EMA) to find the persons responsible for the counterfeit packs.

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