In its news of August 12, 2024, the National Agency for the Safety of Medicines and Health Products (ANSM) indicates that a batch Daflon 500 mg is being recalled due to a quality defect. It contains traces of trimetazidine, a “prescription medication used forangina pectoris in adults”, specifies the ANSM which adds that “this medicinal substance is not included in the composition of Daflon”.
It should be noted that, according to the Agency, the quantities are “very weak” et “do not pose a risk to patients who may have been exposed to them.” Moreover, “no pharmacovigilance cases related to this quality defect have been reported” to this day.
Recall of a batch of Daflon 500mg (n°6068122) due to the presence of traces of trimetazidine
↪️ Check the lot number of your box
🛑 If this lot number is listed👉Return your box to the pharmacy for exchange➕d’info : https://t.co/W3QC91yWCr pic.twitter.com/5HKjg7RCwe
— ANSM (@ansm) August 12, 2024
Daflon 500 mg recall: which batch is affected?
Daflon 500 mg is “a drug available without a prescription for the treatment of venous circulation disorders (heavy legspain, and restlessness) and functional signs related to the hemorrhoidal crisis”, explains the ANSM on its website. After laboratory analyses, “Daflon lot 6068122 showed traces of trimetazidine”. Also, “investigations are currently being carried out to determine its origin,” specifies the ANSM which underlines that “other batches marketed in France are not affected”.
To find out if your box is part of the batch of Daflon 500 mg affected by this recall, the ANSM explains that “the batch number is on the box of your medicine”. If in doubt, take the box to your pharmacist who will check the batch number.
Quality defect in a batch of Daflon 500mg: what should patients do?
If you are in possession of a box of Daflon 500 mg from batch 6068122 then the ANSM calls for you to return the box to the pharmacy where a new box will be provided to you. In addition, the authorities specify that “Pending the exchange of your box, your treatment can be interrupted without risk”.
In addition, the ANSM calls on pharmacists to “contact patients who may hold the batches affected by this recall, in order to present to them the reasons and procedures for the recall”. Finally, posters are also made available by the laboratory.
Source :
- Recall of a batch of Daflon 500 mg due to a quality defect – National Agency for the Safety of Medicines and Health Products (ANSM) – August 12, 2024
