Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US. This recall has been initiated due to the observation of crystal formation in some bottles of the product, which could potentially result in incorrect dosing. It is important to note that no other Sandimmune formulations are impacted by this recall.
Sandimmune® Oral Solution, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Additionally, it may be used in the treatment of chronic rejection in patients who have previously been treated with other immunosuppressive agents.
Risk Statement: Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, potentially leading to under-dosing or over-dosing. Under-dosing may result in lower exposure and decreased efficacy, which could ultimately lead to graft rejection and graft loss in transplant patients. Over-dosage, on the other hand, may manifest as cyclosporine toxicity in the long term if overexposure continues. As of now, Novartis has not received any reports of adverse events related to this recall.
The affected lot number and expiration date are as follows:
• Lot Number: FX001691
• Expiration Date: 12/2025
This specific lot was distributed nationwide to wholesalers across the US, with distribution beginning in April 2023.
Novartis is taking proactive measures to address this issue. The company is notifying its distributors through a recall notification letter and is making arrangements for the return of the recalled lot from distributors, retailers, and consumers. Additionally, Novartis is directly contacting healthcare providers who have prescribed this product, urging them to contact their patients regarding this recall.
Consumers who possess bottles from the recalled lot of Sandimmune Oral Solution, 100mg/mL, are advised to promptly contact their healthcare provider for further guidance.
Reporting Adverse Reactions or Quality Problems: In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their healthcare provider and Novartis to report the event or finding. Patients or healthcare providers can reach the Novartis customer interaction center at 888-NOW-NOVA (888-669-6682) from 8:30 AM – 5:00 PM ET Monday through Friday. Alternatively, adverse events can be reported through the Novartis website or by emailing usdrugsafety.operations@novartis.com.
Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program online or via regular mail or fax. This recall is being conducted with the knowledge and cooperation of the U.S. Food and Drug Administration.
