HPS Pharmacies wish to give notice that Novartis Pharmaceuticals, in consultation with the Therapeutic Goods Administration (TGA), has initiated a product defect correction for Water for Injection (WFI) ampoules co-packed with Simulect® 20mg vials as follows:

Simulect® Vials
Basiliximab 20mg
ARTG 66740

This product defect correction was initiated following the identification of process-related particles in the WFI ampoules that are co-packed with the Simulect® vials. There have not been any reports of quality complaints or adverse effects related to this issue.

This product defect correction only applies to WFI ampoules with the batch number: M0797 (contained in Simulect® packs with a batch number of SHMR6).

Simulect® vials from the affected batch may continue to be safely used with an alternative WFI ampoule. Replacement WFI ampoules should be free from additives and compliant with the European Pharmacopoeia.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Novartis Pharmaceuticals on 1800 671 203 or your pharmacist at HPS Pharmacies.

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