Published on
updated on
Reading 2 min.
A new health alert hits France: more than 110,000 boxes of amoxicillin urgently recalled. This recall concerns one of the most prescribed antibiotics in France.
On August 21, 2024, the National Agency for the Safety of Medicines and Health Products (ANSM) launched an alert concerning a quality defect affecting four batches of amoxicillin 1 g dispersible tablet. This antibiotic, produced by two laboratories, was massively distributed on French territory. The problem ? Microbiological test results deemed non-compliant. As a result, 110,000 boxes of the drug are being recalled to avoid any risk to patients.
A significant risk
The Teva Santé and Sandoz laboratories, in agreement with the ANSM, are recalling the following batches from pharmacies:
- Amoxicillin Teva Santé 1 g dispersible tablet; batches MT2985, MS8574 and MS8584;
- Amoxicillin Sandoz 1 g dispersible tablet; batch MR8824.
The investigations carried out by the laboratories are still ongoing but measures have been put in place to verify that other batches of amoxicillin are not affected and to avoid the recurrence of this defect.
No serious health alerts have been reported at this stage
Amoxicillin, widely used to treat bacterial infections such as tonsillitis or respiratory infections, is a mainstay of medical prescriptions. However, non-compliant microbiological tests revealed a potential risk to patient safety, although the precise details of the failures were not explained by the ANSM.
The health authorities want to be reassuring by affirming that no serious health alert has been reported at this stage. However, as a precaution, patients are asked not to use the batches concerned and to return them to the pharmacy.
Increased vigilance required
Even if the ANSM specifies that “This batch recall does not impact the coverage of patients’ needs for amoxicillin 1 g“, the recall of this drug comes in a context where the availability of antibiotics, particularly amoxicillin, is already strained due to recurring shortages.
Faced with this situation, pharmacies are on the front line to manage the massive return of these boxes.
This case highlights once again the importance of rigorous controls in the manufacturing of medicines, controls which, in this case, revealed anomalies before they could cause harm.