Novartis is recalling a single batch of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles.
This could lead to incorrect dosing, and potential health risks for consumers, patients, health professionals, pharmacies, and transplantation centers that use the product. The affected lot number is FX001691, with an expiration date of 12/2025. This lot was distributed nationwide to wholesalers across the US, starting from April 2023. No other Sandimmune formulations are impacted.
Crystallization of cyclosporine in Sandimmune Oral Solution may result in non-uniform distribution of the cyclosporine in the product, which in turn may lead to under-dosing or over-dosing. Under-dosing may lead to lower exposures and decreased efficacy which could ultimately lead to graft rejection and graft loss in transplant patients. Over-dosage may cause cyclosporine toxicity in the long term if overexposure continues.
Novartis has not received any reports of adverse events related to this recall, to date.
Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL is a drug used to prevent 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.
If you have purchased Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, please check the lot number and expiration date. If you have bottles from the recalled lot, please contact your healthcare provider immediately. Novartis is notifying healthcare providers who have prescribed this product to contact their patients.
If you have experienced an adverse reaction or quality problem involving this product, please contact your healthcare provider and Novartis to report the event or finding. Patients or healthcare providers may call the Novartis customer interaction center for more information about this recall. |
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