Notification on possible occurrence of falsified medicines Retacrit, Silapo and Eporatio on the EU market
22.09.2014
The German competent authority for medicines has notified HALMED that certain amount of erythropoietin-containing medicinal products has disappeared from stocks of an authorised wholesaler. Taking account that disappeared medicines have been outside the legal cold chain, or controlled storage conditions, they will be considered as counterfeit, should they be placed again on the market.
Suspected counterfeited medicines are the following batches:
- Retacrit 2.000 IU/0.6 ml solution for injection in pre-filled syringe, batch No 3T002V3, expiry date 12/2015
- Retacrit 3.000 IU/0.9 ml solution for injection in pre-filled syringe, batch No 3X016Y3, expiry date 04/2016
- Retacrit 4.000 IU/0.4 ml solution for injection in pre-filled syringe, batch No 3T013U3, expiry date 12/2015
- Retacrit 6.000 IU/0.6 ml solution for injection in pre-filled syringe, batch No 3T010V3, expiry date 12/2015
- Retacrit 8.000 IU/0.8 ml solution for injection in pre-filled syringe, batch No 3T008V3, expiry date 12/2015
- Retacrit 10.000 IU/1.0 ml solution for injection in pre-filled syringe, batch No 3E351F3, expiry date 12/2015
These batches have never been placed on the Croatian market.
In addition, among disappeared medicines are also Silapo IU/0.6 ml (batch: 3T001V4, expiry date: 12/2015) and Eporatio 20 000 IU/1 ml (batch O01062001C, expiry date: 05/2015) and Eporatio 30 000 IU/1 ml (batch: O01060001C, expiry date: 05/2015) that have never been placed on the Croatian market.
Even though these batches have never been distributed in the Republic of Croatia, all wholesalers and healthcare professionals are warned to pay special attention when distributing and handling these medicines. In the case of any suspected counterfeited medicine, a report should be sent to HALMED by e-mail: krivotvorine@halmed.hr.
HALMED has never received any suspected counterfeit report to these medicines, or quality defect or suspected adverse reaction that would indicate a counterfeited medicine. HALMED will continue to closely monitor the safe use of these medicine and will inform the public promptly about any new findings.
