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PHOTO: PIXABAY
PHOTO: PIXABAY
Novartis recalls organ rejection medication
Dawn Furnas//November 27, 2023//
Novartis has issued a recall of two lots of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the U.S. because of crystal formation in some bottles, which could potentially lead to incorrect dosing, the East Hanover-based drugmaker announced Nov. 24.
Packaged in 50 mL bottles, the product is used to prevent organ rejection in kidney, liver and heart allogeneic transplants and may also be used to treat chronic rejection in patients previously treated with other immunosuppressive medications, according to the company.
To date, Novartis has not received any incident report related to this recall.
Distributed only in the U.S., the affected lot numbers and expiration dates are: FX001500 (expiration date 09/2024) and FX001582 (expiration date 09/2024) NDC 0078-0110-22. They were distributed nationwide to wholesalers, beginning in January 2022 and September 2022, respectively.
The company said it is notifying these distributors as well as health care providers who prescribe the product. The company said the U.S. Food and Drug Administration also has been alerted to the recall, which was published on its website Nov. 27.
Consumers who have any of the affected bottles or who experience an issue with the product should contact their health care provider. Patients or health care providers may also contact Novartis at 888-NOW-NOVA (888-669-6682) from 8:30 a.m. – 5 p.m. ET Monday through Friday; report an issue by clicking here; or email [email protected].
Consumers may also report issues to the FDA’s MedWatch Adverse Event Reporting program online by clicking here. To report by regular mail or fax, consumers may download a form by clicking here 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 800-FDA-0178.
Novartis issued a similar recall for the product in September.
