Novartis Voluntarily Recalls Two Lots of Sandimmune Oral Solution, 100 mg/mL

On Nov. 24, 2023, Novartis issued a voluntary nationwide recall at the consumer level in the United States of two lots of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to the formation of crystals, which was observed in some bottles. Crystallization could potentially result in incorrect dosing.

The crystallization issue was identified during an investigation of crystallization in a different lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. According to a company statement, no other Sandimmune formulations are impacted.

The product, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It may also be used to treat chronic rejection in patients previously treated with other immunosuppressive agents.

The company released the following 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. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if over exposure continues. Novartis has not received any reports of adverse events related to this recall, to date.”

The lot numbers and expiration dates affected by this recall are: FX001500 (expiration date 09/2024) and FX001582 (expiration date 09/2024) NDC 0078-0110-22. The company has stated that these lots were only distributed in the US and that they were distributed nationwide to wholesalers across the country starting in January 2022 and September 2022, respectively.

The company is notifying distributors by letter and is arranging the return of the recalled lots from distributors, retailers, and consumers. Novartis is also notifying health care providers to contact patients who have been prescribed this medication. Consumers who obtained bottles from the affected lots should contact their individual health care provider.

In the event of an adverse reaction or quality problem involving this product, patients are encouraged to immediately contact their health care provider and Novartis to report the event or finding. Patients or health care providers can contact the Novartis customer interaction center at 888-NOW-NOVA (888-669-6682) or may report an adverse event through https://www.novartis.com/report or usdrugsafety.operations@novartis.com.

In addition, adverse reactions or quality problems experienced with this product can be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

For online reporting, go to www.fda.gov/medwatch/report.htm. For regular mail, download the form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, which should be completed and returned to the address on the pre-addressed form. If reporting by fax, submit to fax number 1-800-FDA-0178.

Source: Novartis