Novartis announced a Consumer Product Safety Commission (CPSC)-approved corrective action plan after identifying certain blister card packages (blister packs) of SANDIMMUNE (cyclosporine capsules, USP) 100-mg soft gelatin capsules and NEORAL (cyclosporine capsules, USP) MODIFIED 100-mg soft gelatin capsules distributed in the U.S. do not meet child-resistant packaging requirements, posing a potential risk of harm.

Novartis notified the CPSC and the FDA and is working closely with the CPSC to remedy the packaging issue and ensure continuity of treatment. An appropriate solution was identified in cooperation with the CPSC.

This action is only necessary because the blister packs at issue do not meet U.S. child-resistant packaging requirements. There are no quality or efficacy issues with the medicines for their intended use. Patients should continue to use the medicine as prescribed, secure impacted blister card packages and their contents to keep out of the sight and reach of children.

To avoid a drug shortage, as an interim measure until child-resistant packaging is available, Novartis is providing child-resistant, resealable pouches to patients with the affected medicines in their homes and to pharmacies to use in dispensing current inventory and future shipments of SANDIMMUNE and NEORAL soft gelatin capsules 100-mg. The company is developing new packaging to meet CPSC child-resistant packaging requirements.