Novartis issues voluntary recall of oral cyclosporine Sandimmune due to crystallization concerns
Novartis has started a nationwide recall of one lot of its cyclosporine oral solution Sandimmune due to crystal formation that can lead to incorrect dosing. The FX001691 batch is being recalled, which was distributed in the US from April 2023 to wholesalers across the country.
The immunosuppressant Sandimmune 100 mg/mL is packaged in 50 mL bottles and used for the prevention of organ rejection in kidney, liver and heart allogeneic transplants. It is also used to treat chronic rejection where other immunosuppressive therapies are not effective.
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