| TGA Action ID |
RC-2023-RN-00348-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Water for Injection (WFI) ampoules co-packed with Simulect 20mg vials
FP Batch # SHMR6 and WIF batch # M0797
ARTG 66740
(SIMULECT basiliximab (rmc) 20mg powder for injection vial and diluent ampoule) |
| ARTG Number |
66740 |
| Action Type |
Product Defect Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In course of an ongoing investigation, Novartis identified potential presence of process related particles in WFI ampoules co-packed with marketed Simulect product. The two identified impacted batches of WFI were co-packed with Simulect 20mg vials into finished product batches.
To date there have been no cases with quality complaints neither any adverse events reported for this issue. |
| Instructions for Customers/Users |
Novartis notes that the WFI ampoule co-packed with the noted batch of Simulect had been removed and the pack resealed with the drug vial only. Customers can continue to use the Simulect 20mg vials by using WFI ampoules (Water for Injections compliant with European Pharmacopoeia, without any additives) from another source.
This action has been closed out on 26/02/2024 |
| Action Commencement Date |
13/04/2023 |
| Responsible Entity |
|
| Contact Information |
1800 671 203 - Novartis Medical Information |