Novartis recalls Sandimmune Oral Solution (100 mg/mL, 50mL) with crystallization risk. Affected lots from Huningue, France, expire 09/30/2024.
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Novartis has recalled a specific dose of Sandimmune Oral Solution (cyclosporine) due to crystals forming in the bottles. This could cause issues for patients taking immunosuppressants, as crystals might affect the medication's safety and effectiveness.
Crystals in the solution can alter the medication's composition and potentially cause inconsistent dosing. This may lead to ineffective treatment or adverse reactions in immunosuppressed patients.
Patients prescribed Sandimmune Oral Solution by a doctor. Those with the specific lot numbers (FX001500, FX001582) and expiration date 09/30/2024 are most at risk.
Check for the product name 'Sandimmune Oral Solution', 100 mg/mL concentration, 50 mL bottle, and lot numbers FX001500 or FX001582. The expiration date is 09/30/2024.
Identify the lot number and expiration date on the bottle label to confirm if it's affected.
The product is not safe for use as recalled due to crystallization risk. Patients should not use the affected lots.
Contact Novartis directly to confirm if your product is affected and follow their instructions.
Check for lot numbers FX001500 or FX001582 with expiration date 09/30/2024.
We’ve drafted a message you can send Novartis to request your refund or repair — edit it as you like.
Subject: Recall D-0144-2024 — Novartis Novartis Hello, I own a Novartis that is covered by recall D-0144-2024 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.
