Novartis recalls Sandimmune Oral Solution (100 mg/mL, 50mL bottle) due to crystallization in bottles. This may affect immunosuppressant medication safety for patients with organ transplants.
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Novartis has recalled a specific immunosuppressant medication (Sandimmune Oral Solution) because some bottles contain crystals. This could potentially affect the medication's safety for patients who require it after organ transplants.
Crystals in the medication can cause inconsistent dosing or potential irritation if the solution is ingested. This may lead to improper medication levels in the body, which could affect transplant outcomes.
Patients with organ transplants who use this immunosuppressant medication are most at risk. The affected product is a prescription-only oral solution for cyclosporine.
Check for the 100 mg/mL, 50 mL bottle labeled 'SANDIMMUNE Oral Solution (cyclosporine oral solution, USP)' with NDC 0078-0110-22. The product was manufactured by DELPHARM in France and distributed by Novartis.
Look for the specific product label: SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, NDC 0078-0110-22.
The recall is due to crystallization in some bottles, which may affect medication consistency. Patients should not use the recalled product and contact their healthcare provider for alternatives.
Check the label for SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle with NDC 0078-0110-22. The product was manufactured by DELPHARM in France and distributed by Novartis.
The recall does not specify a remedy, so contact your healthcare provider for guidance on safe alternatives or next steps.
We’ve drafted a message you can send Novartis to request your refund or repair — edit it as you like.
Subject: Recall D-1174-2023 — Novartis Novartis Hello, I own a Novartis that is covered by recall D-1174-2023 from Novartis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
