Novartis recalls Sandimmune oral solution due to crystallization concerns

Nov. 27, 2023

Novartis has issued a voluntary nationwide recall of two lots of its Sandimmune (cyclosporine) oral solution at the consumer level in the U.S., following crystallization concerns.

In a statement, the drugmaker said the affected product is the 100 mg/mL concentration, packaged in 50 mL bottles. The issue came to light during an investigation into crystallization in a different lot of the solution, and the recall was prompted by the potential risk of incorrect dosing resulting from crystal formation observed in some bottles. 

Sandimmune oral solution, indicated for the prophylaxis of organ rejection in kidney, liver and heart allogeneic transplants, may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

The risk associated with the crystallization of cyclosporine in the oral solution lies in the potential for non-uniform distribution, leading to under-dosing or over-dosing. Under-dosing may result in lower exposures, decreasing efficacy, and potentially leading to graft rejection and graft loss in transplant patients. On the other hand, over-dosage could manifest as cyclosporine toxicity in the long term if overexposure continues.

As of the recall announcement, Novartis has not received any reports of adverse events related to this issue. The affected lots can be identified as; FX001500 (expiration date 09/2024) and FX001582 (expiration date 09/2024) with NDC 0078-0110-22. 

Just a few weeks ago, Bayer also recalled one lot of its cancer medication Vitrakvi due to the discovery of microbial contamination during routine stability testing. The affected lot, comprised of 192 glass bottles, which were distributed to wholesale distributors and specialty pharmacies between January 3 and February 13, 2023. Despite the identification of Penicillium brevicompactum as the contamination source and the potential risk to immunocompromised Vitrakvi patients, Bayer reported no adverse events since the recall.