13,000 boxes of medicines are said to be affected.
The French National Agency for the Safety of Medicines and Health Products (ANSM) has been informed by Servier Laboratories of the presence of traces of another medicine in a batch of Daflon© 500mg, even though this medicinal substance is not part of its composition. This discovery has led to a recall of the boxes affected by this defect, with 13,000 boxes of medicines reportedly affected.
Daflon© is a drug from the Bioflavonoid family marketed by Servier laboratories. It is available without a prescription in the treatment of venous circulation disorders (heavy legs, pain, etc.) and functional signs related to hemorrhoidal crises. However, traces of trimetazidine, a prescription drug used for angina in adults, have been identified in a batch of Daflon© 500mg. According to the information available to date, it would appear that the amount of trimetazidine present in Daflon© does not represent an immediate danger for patients. : “According to the analyses carried out by the laboratory on this batch, the very small quantities of trimetazidine detected do not present a risk for patients who may have been exposed to it.”declares the Ansm in its press release from Monday, August 12, 2024. However, the batch affected by this defect is now subject to a recall.
According to the Ansm, the batch affected by this defect is number 6068122 (box of 60 tablets). Other boxes of Daflon© are not affected by this recall. Patients who have a box of Daflon© 500mg bearing this number at home are invited to return it to the pharmacy so that it can be replaced. In case of doubt, it is possible to return the box of Daflon© so that the pharmacist can check the batch number himself. “Pending the exchange of your box, your treatment can be interrupted without risk”reassures the agency.
Investigations are currently underway to determine the origins of this defect. To date, no pharmacovigilance cases related to this quality defect have been reported.