Novartis pulls 2 batches of Sandimmune after spotting crystal formations—again

After pulling one lot of Sandimmune in September due to the unexpected formation of crystals in some bottles, Novartis is once again recalling two batches of the drug.

The company has flagged crystal formation in “some bottles” of the 100 mg dose of Sandimmune oral solution, Novartis said in a recent statement. The issue came to light during an investigation of crystallization in a different lot and doesn’t impact other Sandimmune formations, the company noted.

Crystallization of Sandimmune’s active ingredient, cyclosporine, can lead to under-dosing or over-dosing of the medicine due to non-uniform distribution. The drug is used to prevent organ rejection in patients who've had kidney, liver or heart transplants, meaning under-dosing could potentially cause transplant rejection.

Over-dosage, meanwhile, could ultimately result in cyclosporine toxicity.

The company has so far not received reports of any adverse effects relating to the recall. The affected lots were distributed nationwide to U.S. wholesalers between January 2022 and September 2022. Both batches both expire in September 2024.

Aside from the crystallization recall earlier this year, Novartis has pulled batches of the immunosuppressant before. In 2020, the company pulled a batch of its 100 mg Sandimmune after the blister packs were found to not be child-resistant.