Novartis announces nationwide recall for two lots of Sandimmune Oral Solution

Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune Oral Solution, 100 mg/mL in the U.S. 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, 100 mg/mL. No other Sandimmune formulations are impacted. Sandimmune Oral Solution, 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.