Last Updated on September 17, 2023 by The Health Master
This action has been taken due to the identification of crystal formation in some bottles, potentially leading to incorrect dosing.
It is crucial to note that only one lot of Sandimmune® is affected, and other formulations remain unaffected by this issue.
Details of the Drug recall
1. Affected Product:
- Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL
- Packaged in 50 mL bottles
2. Intended Usage:
- The product is primarily used for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
- It may also be utilized in the treatment of chronic rejection in patients who have previously been treated with other immunosuppressive agents.
The crystallization of cyclosporine in Sandimmune Oral Solution raises concerns about the uniform distribution of the drug in the product.
This non-uniformity may lead to either under-dosing or over-dosing, both of which can have serious implications:
- Under-dosing: This scenario may result in lower exposures, potentially decreasing the drug’s efficacy. Ultimately, this could lead to graft rejection and loss in transplant patients.
- Over-dosing: Prolonged over-exposure may manifest as cyclosporine toxicity in the long term.
- Affected Lot Number: FX001691
- Expiration Date: 12/2025
- Distribution Commencement: April 2023
- Distribution Area: Nationwide to wholesalers across the US
Response and Actions
In light of the recall, Novartis is taking the following steps:
- Distributors are being promptly informed through recall notification letters.
- Arrangements are being made for the return of the recalled lot by distributors, retailers, and consumers.
- Health care providers who have prescribed this product are being notified to contact their patients.
- Consumers possessing bottles from the recalled lot are advised to get in touch with their health care provider.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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