Reactions 1664, p1 - 12 Aug 2017
European recalls of counterfeit
The Danish Medicines Agency (DKMA) and European
parallel importers are recalling counterfeit batches of the
schizophrenia medicine, paliperidone (Xeplion).
The first set of recalls was announced late last month
by the DKMA, involving one German and several Danish
parallel importers that withdrew several batches of
Xeplion 150mg injections from wholesale distributors,
hospitals and pharmacies.
The case originally started in Germany when the
parallel importer Haemato Pharm discovered
counterfeit packs in one batch of Xeplion 150mg. At
least three batches of the product were found to contain
both authentic packs and an unknown number of
counterfeit packs. Haemato Pharm and a number of
Danish parallel importers have restocked packs from the
affected batches, and several parallel importers have
confirmed they have counterfeit packs in stock.
Janssen (i.e. the manufacturer of Xeplion 150mg)
examined one of the counterfeit packs from the two
initial batches affected, which were manufactured for
sale in Bulgaria and Romania. The company found a
number of ways that the counterfeit packs differed from
authentic packs, including: (i) different shade of blue on
the pack; (ii) outer packaging appeared older; and (iii)
inner packaging was of a more recent date and
contained needles with a different expiry date.
The company also analysed the contents of a prefilled
syringe in a counterfeit pack, revealing that "the syringe
contained the correct active substance in the appropriate
quantities". However, the agency highlighted that it
could not be ruled out that the packs had been stored
improperly given they were packed outside the legal
thereby making them counterfeit medicines.
The market withdrawal of a fourth set of counterfeit
batches of Xeplion 150mg injections was announced at
the beginning of August.
Janssen has analysed a total of seven counterfeit packs
from the second batch and found that while the outer
packaging had been falsified, the syringe, its contents
and the enclosed needles were all authentic products.
Overall, the DKMA considered that the risk that
patients had been injected from a counterfeit pack was
low. Batches that have an identified risk of falsification
will remain under quarantine at the parallel importers
and withdrawn from the market, and will not be released
until their authenticity can be established.
As per the DKMA’s request, information will be sent
to psychiatrists and general practitioners about how to
check for counterfeit Xeplion 150mg packs, as well as
providing information about possible alternative
* Other strengths of Xeplion are available, and another product with
the same active substance is also available on the market.
1. Danish Medicines Agency. Counterfeit packs of the schizophrenia medicine
Xeplion 150 mg. Internet Document : 25 Jul 2017. Available from: URL: https://
2. Danish Medicines Agency. Withdrawal of one more batch of counterfeit packs
of the schizophrenia medicine Xeplion 150 mg. Internet Document : 1 Aug
2017. Available from: URL: https://laegemiddelstyrelsen.dk/en/news/2017/
Reactions 12 Aug 2017 No. 16640114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved