Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization

September 11, 2023 - Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune^® Oral Solution (cyclosporine oral solution, USP), 100mg/mL in the U.S. due to crystal formations observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune formulations are impacted.

Sandimmune^® Oral Solution (cyclosporine oral solution, USP), 100mg/mL, packaged in 50mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously 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, resulting in under-dosing or over-dosing. There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients.

The affected lot number and expiration date is: FX001691 (expiration date 12/2025). This lot was distributed nationwide to wholesalers across the U.S., beginning in April 2023.

Novartis is notifying its distributors via a recall notification letter and is arranging for the return of the recalled lot from distributors, retailers, and consumers. Additionally, Novartis is notifying health care providers who have prescribed this product to contact their patients. Consumers that have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, should contact their health care provider.

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their health care provider and Novartis to report the event or finding. Patients or health care providers may call the Novartis customer interaction center at 888-NOW-NOVA (888-669- 6682) from 8:30 AM - 5:00 PM ET Monday through Friday or may report an adverse event through https://www.novartis.com/reportExternal Link Disclaimer or usdrugsafety.operations@novartis.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

No members of BeneCard PBF/BCF were affected by this recall.