Quality & complianceOfficial

Austria recalls Mynzepli pre-filled syringe batch over defective finger flanges

🇦🇹 BASG · Thu 29 Oct 2026

BASG reports a pharmacy-level recall of one Mynzepli 40 mg/ml batch after the marketing authorisation holder identified faulty grip aids on the syringes.

Austria's medicines agency BASG has published a recall of one batch of Mynzepli 40 mg/ml solution for injection in pre-filled syringes. The notice is dated 29 October 2026 and classes the recall as risk class 2.

According to BASG, the marketing authorisation holder, Advanz Pharma Limited, wrote to its customers on 29 October 2026. It said the batch was being withdrawn because the syringes' grip aids, known as finger flanges, were defective.

The affected batch is 2325718, with an expiry date of 31 May 2027. The product is authorised under EU/1/25/1964/002 and carries the Austrian Pharmazentralnummer 6060902. The recall extends down to pharmacy level.

The notice gives no further detail on the nature of the flange defect. It also does not say whether any adverse events or administration problems have been reported, or whether other countries are affected. Queries can be sent to BASG's quality-defect mailbox, am-qualitaetsmangel@basg.gv.at, under reference BASG INS-640.001-5907.

For context, a class 2 recall generally denotes a quality defect that could cause temporary or less serious health problems, rather than one posing an immediate serious risk.

What it means for your team

  • Quality teams should check whether batch 2325718 (expiry 31 May 2027) is held in Austrian supply chains and quarantine any stock found.
  • Pharmacies and wholesalers supplied with the batch should follow the instructions in the marketing authorisation holder's customer letter of 29 October 2026.
  • Pharmacovigilance teams may wish to watch for reports of handling or administration difficulties linked to the syringe, although the notice mentions none.
  • Regulatory affairs teams outside Austria should check whether the batch was distributed in other markets, as the notice does not specify this.

Official source: BASG ↗

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

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