Quality & complianceOfficial

MHRA issues Class 2 recall of two Mynzepli aflibercept syringe batches over finger grip variation

🇬🇧 MHRA alerts · Thu 29 Oct 2026

Advanz Pharma is recalling two batches of Mynzepli 40 mg/mL pre-filled syringes as a precaution, after a small variation in finger grip size was found that could affect administration.

The MHRA published a Class 2 medicines recall (EL(26)A/44) on 29 October 2026 for specified batches of Mynzepli 40 mg/mL solution for injection in pre-filled syringe. The marketing authorisation holder, Advanz Pharma Limited, is carrying out the recall as a precautionary measure. The active ingredient is aflibercept (PL 56734/0022).

Two batches are affected: 2325742, with an expiry date of June 2027 and first distributed on 2 January 2026, and 2325726, expiring May 2027 and first distributed on 10 October 2025. Both are single-syringe packs. The alert gives the GTIN as 05021691005605 and the DMRC reference as 41252013.

According to the notice, a small variation in the size of the finger grip could affect how the medicine is administered and potentially pose a risk to patient safety. The finger grip, or flange, gives the user a surface to hold the syringe securely while pressing the plunger rod during administration.

Healthcare professionals are told to stop supplying the affected batches immediately, quarantine remaining stock and return it to their supplier through the supplier's approved process. Advanz Pharma has confirmed that unaffected batches of Mynzepli are available for distribution.

The recall is at pharmacy and wholesaler level, so patients need take no action. The product is administered only by a qualified healthcare professional experienced in intravitreal injections. Patients with adverse reactions or questions should seek medical attention, and suspected reactions should be reported through the MHRA Yellow Card scheme. Advanz Pharma's medical information team can be reached at medicalinformation@advanzpharma.com or on +44 (0) 208 588 9131.

What it means for your team

  • Quality and supply chain teams should check stock for batches 2325742 and 2325726, quarantine any found and return them via the supplier's approved process.
  • The alert is a device-related defect (finger grip dimension) rather than a stated problem with the medicine itself, so recall handling should be documented accordingly.
  • Pharmacovigilance teams should note the Yellow Card reminder and be alert to any reports involving difficulty administering the syringe.
  • Market access and distribution teams can note that unaffected Mynzepli batches remain available, according to Advanz Pharma.

Official source: MHRA alerts ↗

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

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