Medicine recalls
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| The United States: Novartis issues voluntary US nationwide recall of two lots of Sandimmune® Oral Solution (cyclosporine oral solution, USP) 100 mg/ml due to crystallization |
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The US Food and Drug Administration (FDA) announces that Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP) 100 mg/ml (lot number: FX001500, FX001582) in the United States due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP) 100 mg/ml. No other Sandimmune formulations are impacted.
Crystallization of cyclosporine in Sandimmune® Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing. There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if over exposure continues. Novartis has not received any reports of adverse events related to this recall, to date.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-us-nationwide-recall-two-lots-sandimmuner-oral-solution-cyclosporine-oral
In Hong Kong, Sandimmun Neoral Soln 100mg/ml (HK-38061) is a pharmaceutical product registered by Novartis Pharmaceuticals (HK) Limited (Novartis). It is a prescription-only medicine. As confirmed with Novartis, the affected lots have not been imported into Hong Kong. Related news was previously issued by FDA, and was posted on the Drug Office website on 12 Sep 2023.
Ends/Tuesday, Nov 28, 2023
Issued at HKT 15:00
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