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Novartis Recalls Sandimmune, Neoral Blister Packs In US

novartis march20 lt

Swiss pharmaceutical giant Novartis is recalling certain Sandimmune, Neoral capsules in the United States for hazardous packaging.

The corrective action plan approved by the U.S. Consumer Product Safety Commission or CPSC involves blister packs of Sandimmune (cyclosporine capsules, USP) 100-mg soft gelatin capsules and Neoral (cyclosporine capsules, USP) MODIFIED 100-mg soft gelatin capsules 30-count. The medicines are within expiry and sold in the United States.

Cyclosporine capsules are used to prevent organ rejection after a kidney, heart, or liver transplant. They are also used to treat severe psoriasis or severe rheumatoid arthritis.

Meanwhile, the 25-mg soft gelatin capsules of Sandimmune and Neoral are not included in the recall.

According to the company, the affected blister packs do not meet U.S. child-resistant packaging requirements. There is a potential risk of harm if children open the package and swallow the medicine.

Novartis said the recall is not due to any quality or efficacy issues with the medicines for their intended use, and that the patients can continue taking their medicine.

The consumers can contact the company for a resealable child-resistant pouch free-of-charge to store the blister packs.

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