After crystals unexpectedly formed in bottles of Novartis’ immunosuppressant Sandimmune, the company is pulling one lot of the med.
Sandimmune won FDA approval in 1983 to aid in organ transplants and prevent organ rejection. Specifically, the drug is used for kidney, liver and heart transplants.
Crystallization of the drug’s active ingredient, cyclosporine, can affect its distribution and lead to underdosing or overdosing, according to the FDA’s statement.
Both scenarios can have dangerous effects. Underdosing can end up in graft rejection and graft loss in transplant patients, while overdosing can eventually cause cyclosporine toxicity, which manifests as a range of serious symptoms.
Novartis hasn’t received reports of any such events related to the recalled lot, which is in the drug's 100-mg/mL oral formulation, the FDA said.
The batch in question was shipped across the U.S. in April and expires at the end of 2025.
This isn't Novartis' first recall of the medicine. In 2020, the company pulled a batch over packaging concerns.