This is the second recall of Sandimmune related to the formulation of crystals in some bottles.
Crystal formation observed in some bottles has led Novartis to recall two lots of Sandimmune Oral Solution (cyclosporine), 100 mg/mL. No other Sandimmune formulations are impacted.
Sandimune is used to prevent organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used to treat chronic rejection in patients previously treated with other immunosuppressive agents.
The formulation of crystals could result in non-uniform distribution of the cyclosporine, resulting in under-dosing or over-dosing. Under-dosing would decrease the efficacy of Sandimmune and potentially lead to graft rejection and graft loss in transplant patients. Over-dosage could lead to cyclosporine toxicity in the long term. Novartis has not received any reports of adverse events related to this recall, to date.
The affected lots are FX001500 with an expiration date of September 2024 and FX001582 with an expiration date September 2024. The lots have an NDC number of 0078-0110-22. These lots were only distributed in the United States beginning in January 2022 and September 2022, respectively.
This is the second recall of Sandimmune related to the formulation of crystals in some bottles. Novartis had issued a recall in September 2023 of a different lot.