Novartis recalled two lots of its organ rejection drug Sandimmune because crystallization was discovered in some bottles, the FDA said Nov. 27.
The crystal formations were found during an investigation in a different lot than the two sent to customers and later recalled. Crystallization in drug solutions can disrupt the distribution of the active pharmaceutical ingredient, raising the risk of over- or under-dosing.
The drug is indicated for the prophylaxis of organ rejection in kidney, liver and heart allogeneic transplants, according to the agency. Sandimmune is also used for chronic rejection in patients who have received other immunosuppressive agents.
No adverse events related to the recall have been reported.