Two medication batches recalled due to syringe defects risking eye injury. Patients and pharmacies advised to return affected products.
Recall of two medication batches
A recall has been issued for two batches of medications—AFIVEG 40 mg/mL and MYNZEPLI 40 mg/mL—due to a quality defect in the prefilled syringes used for administration. The defect could lead to ocular injury or an incomplete dose during intravitreal injection.Risk of ocular injury
The defect in the syringe poses a risk during intravitreal injection, which is a procedure where medication is injected directly into the eye. This could result in harm to the eye or the patient receiving an incomplete dose of the medication.Instructions for return and exchange
Patients who have received these medications are advised to return the affected batches to their pharmacy for exchange. Pharmacists must contact patients who have been dispensed these medications and ensure they return the syringes for replacement with a compliant batch.Healthcare professionals must check batch numbers
Ophthalmologists are instructed to verify the batch number of the medication before performing an injection. They must not use medications from the affected batches, and prefilled syringes from these batches should not be used in any treatment.Recall extends across Europe
The recall applies to pharmacies, healthcare facilities, and the pharmaceutical distribution chain across Europe. MYNZEPLI is also undergoing a recall in other European countries, though no cases have been reported in France according to the French National Agency for Medicines and Health Products Safety (ANSM).Medications are biosimilars of EYLEA
AFIVEG and MYNZEPLI are biosimilars of EYLEA 40 mg/mL, an injectable solution used in the treatment of certain eye conditions. These medications are administered via intravitreal injection, a method that requires precise delivery into the eye.Adverse effects reported in Europe
Three cases of ophthalmological adverse effects linked to the quality defect have been reported in two European countries. The origin of the defect has been identified and corrected, and replacement batches are available in sufficient quantity.Pharmacists can substitute medications
Pharmacists are authorized to substitute the affected medications with other products within the aflibercept group, ensuring patients receive effective treatment without interruption. Ophthalmologists are advised to report any adverse events following an injection.
