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Crystal Formation in Bottles Leads to Recall of Sandimmune


Crystal formation could lead under- or over-dosing of Sandimmune oral solution, which is used to prevent organ rejection in kidney, liver, and heart allogeneic transplants.

Novartis is recalling one lot of Sandimmune Oral Solution (cyclosporine), 100 mg/mL because of crystal formation in some bottles, which could lead to incorrect dosing. No other Sandimmune formulations are impacted, Novartis indicated in a press release. Sandimmune is used to prevent organ rejection in kidney, liver, and heart allogeneic transplants.

The crystallization 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 could result in cyclosporine toxicity over the longer term. Novartis has not received any reports of adverse events related to this recall, to date.

The affected lot number FX001691 with an expiration date of December 2025. This lot was distributed nationwide beginning in April 2023.

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