The National Agency for the Safety of Medicines specifies that the batch concerned consists of 13,000 boxes of Daflon 500 mg, a medicine sold without a prescription.
The National Agency for the Safety of Medicines (ANSM) announced on Monday the recall of a batch of Daflon, a treatment commonly used for venous insufficiency, due to traces of a substance medicinal not entering into its composition.
“Traces of trimetazidine, a prescription medication used for angina in adults, have been identified in Daflon lot 6068122.”warns the drug regulator on its website. Questioned by AFP, the ANSM specifies that the batch concerned by the recall consists of 13,000 boxes of Daflon 500 mg, a drug sold without a prescription. “To date, no pharmacovigilance cases related to this quality defect have been reported.”assures the agency, adding that “Investigations are currently being carried out” to determine its origin.
First drug from the Servier group
For the third consecutive year, Daflon remained the group’s leading drug Servier with sales of €594 million for the 2022/23 financial year, according to its financial results published in February.
“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.”the agency points out. It invites patients who have a box of Daflon bearing this batch number at home to “take it back to their pharmacy to have it replaced”.