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Denmark recalls fourth suspect Xeplion batch

The Danish drugs regulator says it has ordered the withdrawal of a fourth batch of Janssen's schizophrenia drug Xeplion suspected of being counterfeit.

The announcement comes a few days after the German authorities warned that a fake batch of Xeplion (paliperidone) 150mg had been discovered which mimicked the packaging for the drug in Bulgaria and Romania.

"The German authorities have informed the Danish Medicines Agency that a German parallel importer has found counterfeit packs in one more batch of Xeplion 150mg," said the agency in a statement.

"This batch has also been sold in Denmark and will be withdrawn from the market," added the DMA, which said the counterfeits had been discovered by a German (Haemato Pharm) and several Danish (Abacus Medicine, Paranova Danmark, EuroPharmaDK and Orifarm) parallel importers.

Janssen has now examined counterfeit packs from two of the affected batches and concluded that while the outer packaging has been falsified, the syringe and its contents - as well as the enclosed needles - are authentic products.

There was no sign that syringes and needles have been manipulated with, suggesting there is a low risk for patients who may have taken the drugs, although the agency notes "it cannot be ruled out that the counterfeit packs have been handled improperly since they were packed and handled outside the legal chain, which by definition makes medicinal products counterfeit."

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.

Xeplion is a prolonged-release (depot) formulation that is generally used to manage schizophrenia patients after they have been stabilised on shorter-acting drugs and, after an induction dose, is delivered once a month.


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