Class 4 Medicines Defect Information: Novartis Pharmaceuticals, Simulect 10mg & 20mg powder and solvent for Solution for injection or infusion

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 4 recall for Novartis Pharmaceuticals, Simulect 10mg & 20mg powder and solvent for Solution for injection or infusion. 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.

Further information, advice and details of the affected batches can be found on the MHRA website.