Novartis recalls lot of Sandimmune due to crystal formation in oral solution

Novartis, drug recall, voluntary recall, contamination, Sandimmune, immunosuppressant, crystal formation

Novartis is taking action to recall one lot of its immunosuppressant medication, Sandimmune, due to an unexpected issue with crystallization that occurred in some bottles of the drug. Sandimmune, which received FDA approval back in 1983, plays a crucial role in aiding organ transplant patients by preventing organ rejection. It is primarily used in kidney, liver, and heart transplant procedures.

The presence of crystals within the drug’s active ingredient, cyclosporine, can disrupt its distribution, potentially resulting in either underdosing or overdosing, as highlighted by the FDA. Both scenarios carry significant risks. Underdosing may lead to graft rejection and graft loss in transplant recipients, while overdosing can trigger cyclosporine toxicity, a serious condition associated with various severe symptoms. Importantly, Novartis has not received any reports of adverse events related to the recalled lot, which is in the 100-mg/mL oral formulation of the drug.

This specific batch, which is subject to the recall, was distributed throughout the United States in April and has an expiration date at the end of 2025. It’s worth noting that this is not the first instance of Novartis recalling Sandimmune. In 2020, the company initiated a recall due to concerns related to the drug’s packaging.

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