Novartis Recalls One Lot Of Sandimmune Oral Solution 100 Mg/mL

(RTTNews) - Novartis AG (NVS) announced Monday it has recalled 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. The company added that no other Sandimmune formulations are impacted.

The company warned that 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.

The recall involves Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, which 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.

Novartis said it has not received any reports of adverse events related to this recall, to date.

The affected lot number and expiration date is: FX001691 with expiration date of December 2025. This lot was distributed nationwide to wholesalers across the US, beginning in April 2023.

Novartis urged consumers having bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, to contact their health care provider.