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Novartis has voluntarily recalled 1 lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to crystal formation observed in certain bottles that may lead to incorrect dosing.
Sandimmune® Oral Solution is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants, in combination with corticosteroids. It is also indicated for the treatment of chronic rejection in patients previously treated with other immunosuppressants.
The recalled product, packaged in 50 mL bottles, was distributed nationwide to wholesalers across the United States starting in April 2023, and includes lot number FX001691 (expiration date 12/2025).
Use of the affected product can potentially lead to underdosing or overdosing due to nonuniform distribution of cyclosporine. To date, the Company has not received any reports of adverse events related to this recall.
Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.
This article originally appeared on MPR
References:
Novartis issues voluntary nationwide recall of one lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to crystallization. News release. Novartis. September 11, 2023. https://www.prnewswire.com/news-releases/novartis-issues-voluntary-nationwide-recall-of-one-lot-of-sandimmune-oral-solution-cyclosporine-oral-solution-usp-100-mgml-due-to-crystallization-301923365.html.
