Safety Report: Novartis Sandimunne Oral Solution - recalled due to crystallization, USA

United States

Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. This lot was distributed nationwide to wholesalers across the US, beginning in April 2023. 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, 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. No other Sandimmune formulations are impacted.

The affected lot number and expiration date is: FX001691 (expiration date 12/2025).

Risk Statement: 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. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if over exposure continues.

Novartis is notifying its distributors via a recall notification letter and is arranging for return of the recalled lot from distributors, retailers and consumers.  Additionally, Novartis is notifying health care providers who have prescribed this product to contact their patients.  Consumers that have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, should contact their health care provider.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Novartis Pharmaceuticals Corporation
Brand name: Novartis
Product recalled: Sandimunne Oral Solution (cyclosporine oral solution, USP) 100 mg/mL
Reason of the recall: Crystal formation which could potentially result in incorrect dosing
FDA Recall date: September 11, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-nationwide-recall-one-lot-sandimmuner-oral-solution-cyclosporine-oral