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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