Novartis issues recall for Sandimmune oral solution due to crystallization

Novartis recall overview: 

• Who: Novartis voluntarily recalled one lot of its 50-milliliter bottles of Sandimmune. 
• Why: A crystal formation was found inside bottles, meaning it could result in improper dosing.
• Where: The Novartis recall is effective across the United States.

Novartis announced a voluntary recall for one lot of its 50-milliliter bottles of Sandimmune due to crystal formation inside the bottles that could lead to misdosing.

The Sandimmune recall states the crystallization could result in nonuniform distribution of the cyclosporine in the drug, which could lead to overdosing or underdosing. A lack of cyclosporine would decrease the effectiveness of the drug, used for prophylaxis of organ rejection in kidney, liver and heart allogeneic transplants.

Overdosage could lead to cyclosporine toxicity over the long term if the exposure continues, according to the Sandimmune recall.

The Novartis recall covers Lot FX001691 with an expiration date of December 2025. Wholesalers distributed the lot nationwide starting in April 2023.

Patients should contact health care provider, Sandimmune recall states

Novartis says it has not received any reports of illness related to the recall. The company is not facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.

Consumers who have the recalled lot of Sandimmune should contact their health care provider. They can also call Novartis at 888-669-6682 from 8:30 a.m. to 5 p.m. EDT, Monday to Friday, visit novartis.com/report or email usdrugsafety.operations@novartis.com.

Novartis previously agreed to a $30 million antitrust class action settlement that is now closed, ending claims it engaged in a price-fixing scheme with company Par for the blood pressure medication commonly known as Exforge.

Are you affected by the Novartis Sandimmune recall? Let us know in the comments. 

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