Novartis pulled one drug lot from the market after finding crystal formation in some bottles, which could lead to incorrect dosing, the FDA said Sept. 11.
The product is Sandimmune oral solution (cyclosporine), which is approved for the prophylaxis of organ rejection in kidney, liver and heart transplants. The drug is also indicated for treating chronic rejection of transplants.
No adverse events have been reported. The crystallization could cause doses to be too strong or weak. The FDA said "there is a reasonable probability" under-dosing can lead to graft rejection and graft loss in transplant patients, and over-dosing could "manifest itself as cyclosporine toxicity in the long term if over exposure continues."
Novartis is contacting healthcare providers who have prescribed the drug and is asking distributors to return their supply.