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AIFA flags Respreeza vial closure defects that may block dosing or risk infection

🇮🇹 AIFA · Wed 04 Nov 2026

CSL Behring has reported stopper defects in specific Respreeza lots, and AIFA's information note warns of missed doses and possible microbial contamination.

Italy's medicines agency AIFA published an Important Information Note on quality for Respreeza (human alpha-1 proteinase inhibitor) on 4 November 2026. It warns of a risk that a dose cannot be given and of a potential infection, because vial integrity may be compromised.

According to the note, CSL Behring received reports of container closure defects in specific Respreeza lots. The affected lots are listed in Table 1 in the note's "Context" section, which is not reproduced in the web text.

In the reported cases, parts of the vial stopper loosened or detached when the Mix2Vial transfer device was removed from the vial after reconstitution. The defects occurred even though the product had been prepared and handled in line with the instructions for use.

The note says the reconstituted product may then be impossible to administer, leading to missed or delayed doses. If the vial is no longer properly sealed, microbial contamination could occur and cause a serious infection.

If the defect appears during reconstitution as described in the product information, the product must not be administered and a product complaint should be filed. The defective vial and the transfer device should be kept and sent to CSL Behring for investigation, and patients will receive replacement product.

Patients who use Respreeza at home should be told by their treating physician or dispensing pharmacy that a compromised vial may prevent administration. They should also be told that the risk of infection cannot be ruled out if product from an affected vial is given.

What it means for your team

  • Quality and QA teams should check the lots in Table 1 of the full note against distribution and stock records.
  • Complaint handling should be ready to receive reports, and defective vials and Mix2Vial devices should be retained and returned to CSL Behring.
  • Pharmacovigilance teams should watch for reports of missed or delayed doses or infections linked to affected vials.
  • Hospital and community pharmacies and prescribers need to brief home-treatment patients on what to do if the stopper fails.

Official source: AIFA ↗

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

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