Novartis recall one lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP) due to crystallisation in US Read More..

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL is indicated for the prophylaxis of organ rejection in kidney, liver, and heart transplants. The recall is due to crystal formation observed in some bottles of the drug. 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. The affected lot number FX001691 is distributed in US, beginning April 2023 and has an expiration date of 12/2025.

Recall announcement