Quality & complianceOfficial

ANSM recalls two aflibercept prefilled syringe batches over detachable finger-flange defect

🇫🇷 ANSM · Thu 29 Oct 2026

France's regulator has withdrawn one batch each of Biogaran's Afiveg and Advanz Pharma's Mynzepli after a syringe flaw that could cause needle movement or an incomplete intravitreal dose.

France's medicines agency ANSM announced on 29 October 2026 the recall of two batches of aflibercept 40 mg/ml solution for injection in prefilled syringes, used for intraocular injection. The products are Afiveg, marketed by Biogaran (batch 2461572, expiry 09/2027), and Mynzepli, marketed by Advanz Pharma (batch 2393229, expiry 06/2027). ANSM says other European countries are also carrying out the recall.

The agency was alerted by the two companies to a manufacturing defect in the syringe, affecting the finger-grip flange. The flange could loosen or detach during injection into the eye. According to ANSM, this could cause involuntary movement of the needle during administration and lead to eye injury, and it could also result in an incomplete dose. Both medicines are indicated for age-related macular degeneration (AMD) and other conditions that reduce visual acuity.

ANSM states that the origin of the defect has been identified and corrected. Three ophthalmic adverse reactions linked to the defect have been reported so far in two European countries, and none in France. The agency says the medicine's quality, including sterility, and its efficacy are not affected, and that patients who have already received an injection from these products are not exposed to a risk related to the defect.

Pharmacists are asked to contact, by any available means, patients who were dispensed a box from the affected batches and have them return it for exchange, following the arrangements communicated by the companies. Replacement batches are said to be available in sufficient quantity. Ophthalmologists are told to check the batch number on every syringe before use, not to use the recalled lots, and to report any adverse event after injection. ANSM's notice also links to the additional risk minimisation measures (MARR) for both products.

What it means for your team

  • Quality and supply teams at Biogaran and Advanz Pharma-linked operations should confirm the two batches (2461572 and 2393229) are quarantined and that exchange arrangements are running with French pharmacies.
  • Pharmacovigilance teams should note the three reported ophthalmic adverse reactions in two European countries and ensure any new post-injection events are captured and reported.
  • Wholesalers, pharmacies and eye clinics need batch-number checks built into dispensing and pre-injection routines for these prefilled syringes.
  • Companies marketing aflibercept in other EU markets should check whether the same recall applies locally, since ANSM says other European countries are also recalling.

Official source: ANSM ↗

Article written by VigiEye from the official source (ANSM). AI-assisted; check the source before acting.

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