Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the U.S. due to crystal formation observed in some bottles, which could potentially result in incorrect dosing.

The issue was identified during an investigation of crystallization in a different lot of Sandimmune Oral Solution 100 mg/mL. No other Sandimmune formulations are impacted.

Sandimmune 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. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

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. There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients.

Over-dosage may manifest itself as cyclosporine toxicity in the long term if over exposure continues. Novartis has not received any reports of adverse events related to this recall, to date.

The affected lot numbers and expiration dates are: FX001500 (expiration date 09/2024) and FX001582 (expiration date 09/2024) NDC 0078-0110-22. 

Novartis is notifying its distributors via a recall notification letter and is arranging for return of the recalled lot from distributors, retailers, and consumers.