Novartis recalls two Lots of Sandimmune Oral Solution (Cyclosporine Oral Solution, USP) due to crystallisation Read More

Sandimmune (cyclosporine oral solution) 100 mg/mL,packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing. Underdosing could ultimately lead to graft rejection and graft loss in transplant patients

Recall Notification