The Danish Medicines Agency (DKMA) announced the latest withdrawal today, just days after revealing that three batches of Xeplion (paliperidone) had been taken off the market.
The Copenhagen-based regulator explained that German authorities had notified it that a Berlin-based parallel importer called Haemato Pharm had found counterfeit packs in a batch of Xeplion.
The DKMA also said several Danish parallel importers – specifically Abacus Medicine, Paranova Danmark, EuroPharmaDK and Orifarm - have all repacked packs from the batches that contain falsified products.
The regulator also said analysis by Janssen-Cilag – which makes Xeplion – suggests the product is genuine and that only the outer packaging is counterfeit.
“They [Janssen] 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” DKMA said.
The investigation by Belgium-based Janssen-Cilag – a subsidiary of Johnson & Johnson (J&J) –indicates that the affected batches were originally manufactured for the Bulgarian and Romanian markets.
According to the DKMA “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."