Recall initiated for two lots of Sandimmune due to crystallization

Sandimmune recall overview: 

• Who: Novartis recalled two lots of its Sandimmune oral solution 100 milligrams/milliliter. 
• Why: The company found a crystal formation in some of the bottles, which could lead to incorrect dosage.
• Where: The Sandimmune recall affects consumers across the United States.

Novartis issued a recall for two lots of its Sandimmune oral solution 100 milligrams/milliliter after it found a crystal formation in some of the bottles.

The company discovered the crystal formation in an investigation after it found a different lot of the product experienced crystallization. The crystal formation can lead to potential improper dosage, the Sandimmune recall says.

The Sandimmune recall applies to 50-milliliter bottles with lot no. FX001500 and expiration date Sept. 2024 along with lot No. FX001582 with expiration date September 2024 and National Drug Code 0078-0110-22.

Sandimmune issued a previous recall of one lot of the solution in September due to the same crystallization issue.

Sandimmune is used for the prophylaxis of organ rejection in kidney, liver and heart allogeneic transplants, the notice states. The crystal formation can lead to a nonuniform distribution of the cyclosporine in the solution.

Underdosing may result in lower exposures and decrease in efficacy that could ultimately lead to graft rejection and graft loss in transplant patients while overdosing can lead to cyclosporine toxicity, according to the recall.

No reports of adverse effects, Sandimmune recall says

Novartis says it has not received any reports of adverse effects 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.

Novartis is looking to recall both lots of the solution from retailers, distributors and customers. Customers can reach the Novartis Customer Interaction Center at 888-NOW-NOVA (888-669-6682) from 8:30 a.m. to 5 p.m. Eastern, Monday to Friday, or report adverse events online or through email at [email protected].

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

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