Novartis issues voluntary recall of one lot of Sandimmune Oral Solution

The FDA said 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. No other Sandimmune formulations are impacted. 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. The affected lot number and expiration date is: FX001691 (expiration date 12/2025). This lot was distributed nationwide to wholesalers across the US, beginning in April 2023. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.