A syringe defect in two eye medications has led to recalls in France and Europe, raising safety concerns for patients.
Syringe defect triggers recall of two medications
The National Agency for Medicinal Product Safety and Health Product Safety (ANSM) has issued an alert about a defect in the syringes used to administer two medications based on aflibercept. The issue has led to the recall of specific batches in France and other European countries.Defect involves syringe component
The defect concerns the finger support collar of the prefilled syringe. This part could loosen or detach during an intravitreal injection, potentially causing the needle to move unexpectedly or delivering an incomplete dose.Adverse effects reported in Europe
Three cases of eye-related adverse effects linked to this defect have been reported in two European countries. However, no such cases have been reported in France. The safety, sterility, and effectiveness of the medications themselves remain unaffected.Pharmacists urged to notify patients
The ANSM is asking pharmacists to contact patients who received the recalled batches using all available means. Patients must be informed of the recall and asked to return the affected packages to the pharmacy for an exchange.Return process includes batch verification
If a patient returns a package voluntarily, the pharmacist must check the batch number. If it is among the affected batches, the pharmacist must proceed with the exchange as outlined by the manufacturers. Replacement supplies are available in sufficient quantity.
