Novartis Pharmaceuticals Corporation is recalling 132,999 cartons of Neoral (cyclosporine) Soft Gelatin Capsules, 25 mg. This medication is used as an immunosuppressant and was found to have ethanol levels that did not meet quality specifications during routine testing. No incidents or injuries have been reported to date, but the deviation from manufacturing standards prompted this voluntary recall.
The drug's ethanol content was found to be outside of the required specifications during stability testing. This quality issue could potentially affect the medication's performance or consistency, which is critical for patients requiring precise immune system management.
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Recall #: D-1543-2022
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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