Novartis Recalls One Lot of Sandimmune Oral Solution

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September 11, 2023
14:24
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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 due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune formulations are impacted.

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL 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.

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

Novartis is notifying its distributors via a recall notification letter and is arranging for 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Consumer Contact: -

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/report

or usdrugsafety.operations@novartis.com.

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.

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Cyclosporine, Cyclosporine recall, Novartis, Novartis recall, Sandimmune, Sandimmune recall

Report a Problem With This Product

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.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Complete a paper Voluntary MedWatch form that can be mailed to the FDA.
https://www.fda.gov/safety/report-problem-fda
Call an FDA Consumer Complaint Coordinator.