Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg

German and Danish parallel importers and the Danish Medicines Agency are now withdrawing the fourth batch of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batch contains counterfeit packs.

The German authorities have informed the Danish Medicines Agency that a German parallel importer has found counterfeit packs in one more batch of Xeplion 150 mg. This batch has also been sold in Denmark and will be withdrawn from the market.

We have now withdrawn a total of four batches.

The risk is still considered to be low

Janssen, the company that manufactures the original medicinal product, has now examined the counterfeit packs from two of the affected batches. Janssen has analysed a counterfeit pack from the first batch and seven counterfeit packs from the second batch. The analyses showed that the outer packaging has been falsified, but the syringe and its content as well as the enclosed needles are authentic products from Janssen. They found no signs that syringes and needles have been manipulated with. Consequently, the Danish Medicines Agency still assesses that there is a low risk for patients who may have been injected with Xeplion 150 mg from a counterfeit pack.

However, 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. All other batches, in which a risk of falsification has been identified, are still placed under quarantine at the parallel importers and are no longer marketed. The packs from these batches will be released from quarantine when it has been established that they are not falsified.

The Danish Medicines Agency has sent information to psychiatrists and general practitioners via the Danish regions. Janssen will send an updated letter shortly to the relevant doctors, including updated information on how to check whether the packs are falsified.

The Danish Medicines Agency continues to investigate this matter in collaboration with the European Medicines Agency and the other affected countries.