Water for injection co-packed with basiliximab (Simulect) 20mg: Recall

Recall Active

Novartis have alerted us to an issue with the water for injection co-packed with basiliximab 20 mg vials (pharmacode 493279).

A small cardboard box containing a glass vial and a glass ampoule. The ampoule is the water for injection and there is a red arrow pointing at the ampoule to indicate which product has the issue. .
Simulect pack showing both the basiliximab vial and the water for injection ampoule.

Affected product

As part of standard testing, Novartis has found that there may be some process related particles (glass) in the water for injection (WFI) ampoule which is co-packed with basiliximab (Simulect).

This issue only affects the water for injection ampoule. The basiliximab vial is unaffected and should be administered using an alternative water for injection. 

  • Product: Basiliximab (Inj 20 mg vial)
  • Brand: Simulect
  • Pharmacode: 493279 

The affected batches:

  • Finished product batch # SFTR2 and WFI batch # M0797
    Product Expiry: 04.2025
  • Finished product batch # SHEN8 and WFI batch # M0797
    Product Expiry: 07.2025

This product is only listed on the Hospital Medicine List(external link)

Actions required

Health care professionals can continue to safely administer the affected Simulect batches. Just exchange the water for injection co-packed with the product with another approved water for injection ampoule, such as:

  • Water for injection, Multichem | Pharmacode 2208326
  • Water for injection, Pfizer | Pharmacode 2511932
  • Water for injection, Fresenius Kabi | Pharmacode 2565692

Health care professionals are asked to:

  1. discard the affected water for injection ampoules
  2. complete Novartis' customer reply form to indicate how many water for injection ampoules have been discarded.

Novartis has written to hospitals to alert them to this issue. Novartis took this action after consultation with Medsafe. Pharmac's role is just to share this information.

Adverse events

If there's any quality problem or any adverse event associated with this product, please report it to CARM as you normally would. 

Reporting to CARM(external link)

Who to contact

If you have questions about this recall, contact Novartis Medical Information on 0800 354 335