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

United States

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 US 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 (cyclosporine oral solution, USP), 100 mg/mL. No other Sandimmune formulations are impacted. They were distributed nationwide to wholesalers across the US, beginning in January 2022 and September 2022, respectively. 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.

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 overexposure continues.

The affected lot numbers and expiration dates are:
- FX001500 (expiration date 09/2024)
- FX001582 (expiration date 09/2024) NDC 0078-0110-22.
These lots were only distributed in the US.

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

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their healthcare provider.

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: Sandimmune (cyclosporine oral solution, USP) Oral Solution 100 mg/mL
Reason for the recall: Due to crystallization formation
FDA Recall date: November 27, 2023

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