Nearly 13,000 boxes of Daflon are affected: recall of the drug due to “a quality defect”

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A batch of the drug Daflon has been recalled since Monday, August 12, 2024 by the French National Agency for Safety and Medicines (ANSM).

The ANSM announced on Monday the recall of a batch of Daflon, a treatment commonly used for venous insufficiency, due to traces of a medicinal substance not included in its composition.

Investigations are being conducted

“Traces of trimetazidine, a prescription drug used for angina in adults, have been identified in batch 6068122 of Daflon”, warns the drug regulator on its website.

Questioned by AFP, ANSM specifies that the batch affected 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. been reported", assures the agency, adding that "investigations are currently being carried out" to determine the origin.

"No risk for patients"

For the third consecutive year, Daflon remained the Servier group's leading drug, 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 emphasizes.

It invites patients who have a box of Daflon at home with this batch number to “return it to their pharmacy so that it can be replaced”.