Novartis has announced a voluntary recall in the US of two lots of its 100mg/mL Sandimmune oral solution (cyclosporine oral solution, USP) over crystallisation issues reported in some bottles.
Crystal formation could result in incorrect dosages.
The recall is at the consumer level and will not impact any other formulations of Sandimmune. Distributors and healthcare providers are being notified.
Available in 50mL bottles, the oral solution treats prophylaxis of organ rejection in patients with allogeneic liver, kidney and heart transplants.
The treatment can also be used for chronic rejection in patients who have already received immunosuppressive agents.
Novartis stated: “Crystallisation 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.
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“There is a reasonable probability that under-dosing may result in lower exposures and a 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.”
The company has not yet received any issues of drug-linked adverse events associated with the recall.
Consumers with bottles from the recalled lot should contact their healthcare provider.
In September 2023, Novartis recalled another lot of 100mg/mL Sandimmune Oral Solution in the US for the same reason.