On November 27, 2023, the U.S. Food and Drug Administration (FDA) reported that Novartis is conducting 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 United States because of crystal formation observed in some bottles that could result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of cyclosporine oral solution, USP, 100 mg/m. No other Sandimmune formulations are affected.
Crystallization is likely to result in nonuniform distribution of the cyclosporine in the product, resulting in under- or overdosing. Novartis acknowledged a reasonable probability that underdosing may result in lower exposures and decrease in efficacy, which could ultimately lead to graft rejection and graft loss in transplant recipients, and that long-term overdosing may manifest as cyclosporine toxicity. Novartis said it has not received any reports of adverse events related to the recall to date.
The affected lots carry the NDC 0078-0110-22 code and were distributed only in the United States to wholesalers:
- Beginning in January 2022: FX001500 (expiration date 09/2024)
- Beginning in September 2022: FX001582 (expiration date 09/2024)
Novartis said that it is notifying distributors via a recall notification letter and arranging for return of the recalled lot from distributors, retailers, and consumers. Additionally, Novartis is notifying healthcare providers who have prescribed the product to contact their patients. Consumers who have bottles from the recalled lot should contact their healthcare provider.
Patients who experience an adverse reaction or quality problem involving the product should immediately contact their healthcare provider and Novartis to report the event or finding. Patients or healthcare providers should report an adverse event to the Novartis Customer Interaction Center at 888-NOW-NOVA (888-669-6682) from 8:30 am–5 pm ET, Monday–Friday, or report it online.
Healthcare providers should report any adverse reactions or quality problems experienced with the use of the product to the FDA’s MedWatch Adverse Event Reporting Program.