The Swiss pharmaceutical firm has recalled the Sandimmune Oral Solution after finding crystal formation in some bottles, which can result in incorrect dosing
Novartis Campus in Basel, Switzerland. (Credit: Novartis AG)
Novartis has issued a voluntary nationwide recall at the consumer level of two lots of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml in the US due to crystallisation.
Sandimmune Oral Solution, packaged in 50ml bottles, is designated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
It can also be used to treat chronic rejection in patients who previously received other immunosuppressive agents.
The Swiss pharmaceutical firm has recalled the drug after finding crystal formation in some bottles, which can result in incorrect dosing.
It was observed during an examination of crystallisation in a different lot of Sandimmune Oral Solution. There is no influence on any other Sandimmune formulations.
The lot numbers and expiration dates that are impacted are FX001500 and FX001582 with the same expiration date of 09/2024 NDC 0078-0110-22.
Novartis said that these lots were only distributed in the US. They were shipped to wholesalers all across the US, starting in January 2022 and ending in September 2022, respectively.
According to the pharmaceutical firm, the cyclosporine in Sandimmune Oral Solution may crystallise and cause a non-uniform distribution of the medication, which could lead to either an overdose or an underdose.
Furthermore, underdosing can lower exposures and decrease efficacy while over-dosage can show up as cyclosporine toxicity in the long term if overexposure persists.
At present, Novartis has not been notified of any adverse occurrences connected to this recall.
The Swiss pharmaceutical firm is coordinating the return of the recalled lot from distributors, merchants, and customers in addition to alerting its distributors through a recall notice letter.
Additionally, Novartis is informing medical professionals who have prescribed this medication to get in touch with their patients.
The company also instructed customers who own bottles of Sandimmune Oral Solution from the recalled lot to get in touch with their physician.
The recall is being conducted with the knowledge of the US Food and Drug Administration (FDA).