Drug Safety Alerts

Sandimmune® 100 mg soft gelatin capsules and Neoral® 100 mg soft gelatin capsules Patient-Level Corrective Action

3/18/2020

On March 18, 2020, Novartis Pharmaceuticals Corporation announced that in cooperation with the U.S. Consumer Product Safety Commission, it is implementing a patient-level corrective action for Sandimmune® 100 mg soft gelatin capsules and Neoral® 100 mg soft gelatin capsules. This corrective action plan was issued because the blister cards in which these Sandimmune and Neoral soft gelatin capsules are packaged are not child-resistant as required by the Poison Prevention Packaging Act, posing a risk of harm if children open the package and swallow the medications. The corrective action is not the result of any quality or safety concerns with the medications for their intended use.

This corrective action plan impacts all lots of Sandimmune and Neoral 100mg capsules.

To avoid a drug shortage, Novartis is providing child-resistant, re-sealable pouches free-of-charge to patients with the affected medications in their homes. This is an interim measure until child resistant packaging is available for the affected medications. Patients should continue to use the medications as prescribed.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this corrective action. We are encouraging patients who are taking Sandimmune 100 mg soft gelatin capsules and/or Neoral 100 mg soft gelatin capsules to contact their prescriber.

For more information about the corrective action, please contact Novartis at 1-888-NOW-NOVA (1-888-669-6682) or visit https://www.novartis.us.