Class 4 Medicines Defect Information: Novartis Pharmaceuticals, Simulect 10mg & 20mg powder and solvent for Solution for injection or infusion, EL (23)A/17

Source: MHRA / Gov.uk 16.5.23

Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may contain glass fragments approximately 20 – 800 µm in size.

MDR number

MDR 070-04/23

Company name

Novartis Pharmaceuticals

Product name

Simulect 10mg powder and solvent for Solution for injection or infusion

SNOMED Code

5007811000001106

Active Pharmaceutical Ingredient: Basiliximab

Product name

Simulect 20mg powder and solvent for Solution for injection or infusion

SNOMED Code

4773411000001103

Active Pharmaceutical Ingredient: Basiliximab

Brief description of the problem

Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may contain glass fragments approximately 20 – 800 µm in size. Therefore, the included solvent should not be used, but replaced with an alternative water for injection. The quality of the Simulect vials themselves is not affected and due to supply considerations, the impacted batches are not being recalled.

The solvent (water for injection in ampoules) shown below in Figure 1 should be discarded as per the advice for healthcare professionals below.

Figure 1 – Solvent (water for injection) ampoule

Advice for healthcare professionals

Novartis Pharmaceuticals has directly notified customers and previously shared considerations for the impacted batches mentioned in this notification. The following actions should be taken:

• discard the solvent (water for injections) co-packed with batches of Simulect at the time of opening the pack. The entire ampoule should be discarded carefully and as per local procedures.
• source alternative water for injection for use as the solvent with Simulect powder. These options should be readily available across secondary care settings.
• the water for injection should comply with European Pharmacopoeia requirements for water for injection, which will be the case if using a licensed product.
• healthcare professionals should continue to safely administer Simulect from the impacted batches using an alternative source of water for injections, following reconstitution as per the Summary of Product Characteristics (SmPC):
  • Simulect 10mg powder
  • Simulect 20mg powder
• forward a copy of this notification to all facilities or departments within your hospital or clinic that may use this product.

Additionally healthcare professionals should complete the Customer Reply Form (Appendix 1 at the bottom of the PDF) and return it to Novartis by email (commercial.team@novartis.com) within 3 working days.

Advice for patients

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. This product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact your healthcare professional.

Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.

Further Information

For more information, medical or supply enquiries, please contact 01276 698370, or email medinfo.uk@novartis.com

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 4 Medicines Defect Information: Novartis Pharmaceuticals, Simulect 10mg & 20mg powder and solvent for Solution for injection or infusion, EL (23)A/17

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