Information on recall of falsified Norditropin SimpleXx 10 mg/1,5 ml solution for injection (somatropin) on the German market
23.05.2014
The Agency for Medicinal Products and medical Devices (HALMED) has received the information about a falsified Morditropim SimpleXx 10 mg/1,5 ml solution for injection (somatropin), used for growth failure and disorders on the German market. A falsified batch of the medicine has been discovered, batch No LL38548, shelf life 10/2015, that has never been released by the manufacturer, Novo Nordisk A/S, Denmark. This falsified medicine is suspected to be purchased in an illicit distribution chain in Germany.
The batch LL38548 has never been distributed on the Croatian market.
This falsified medicine case on the German market was discovered during the investigation following a patient reported quality defect. The investigation revealed the presence of particles of unknown origin and reduced active substance content in the falsified product. The active substance content was approximately 3 mg/ml instead of declared 6,7 mg/ml.
An informing process of healthcare professionals in Germany is currently taking place about the appearance of Norditropin SimpleXx 10 mg/1,5 ml solution for injection and patient protection measures are being undertaken.
Even though this batch has not been distributed in the Republic of Croatia, all healthcare professionals have been alerted to pay special attention when handling and using this medicine. In the case of any suspected falsified medicine, HALMED should be informed by e-mail: krivotvorine@halmed.hr
HALMED continues to monitor closely the situation and will inform the public promptly about any new information.
