Novartis recalls Neoral soft gelatin capsules (25mg) due to ethanol content exceeding specifications during stability testing. This may affect medication safety for immunosuppressed patients.
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Novartis is recalling Neoral soft gelatin capsules (25mg) because stability testing showed ethanol content was out of specification. This could affect medication safety for people with weakened immune systems who take immunosuppressants.
During routine stability testing, the ethanol content in Neoral capsules was found to be outside acceptable limits. This could potentially affect the medication's effectiveness or safety for immunosuppressed patients who require precise dosing.
People prescribed Neoral (cyclosporine) for immunosuppression, such as transplant patients. Those with compromised immune systems are most at risk.
Check for Neoral soft gelatin capsules (25mg, Rx Only) with NDC # 0078-0246-15. The lot number APCD162 was produced in East Hanover, NJ and expires January 2023.
Verify the NDC number 0078-0246-15 and lot number APCD162 on the product packaging.
The recall applies to Neoral capsules with NDC # 0078-0246-15 and lot number APCD162. If you have these specific capsules, you should check with your doctor.
The ethanol content being out of specification could potentially affect the medication's effectiveness or safety for immunosuppressed patients who require precise dosing.
The recall does not require immediate discontinuation. Check the product details and consult your healthcare provider for guidance.
We’ve drafted a message you can send Novartis to request your refund or repair — edit it as you like.
Subject: Recall D-1543-2022 — Novartis Novartis Hello, I own a Novartis that is covered by recall D-1543-2022 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.
