Water for injection co-packed with basiliximab (Simulect) 20mg: Recall
Novartis have alerted us to an issue with the water for injection co-packed with basiliximab 20 mg vials (pharmacode 493279).
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)
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:
- discard the affected water for injection ampoules
- 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.
- CUSTOMER REPLY FORM Basiliximab Novartis [DOCX 21 KB]
- Product Alert WFI basiliximab Novartis [PDF 83 KB]
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