Novartis voluntarily implements corrective action plan for non-child-resistant packs in US

Novartis Pharmaceuticals, in cooperation with the US Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA), has voluntarily implemented a corrective action plan concerning Zofran and Entresto packages in the US.

This CPSC-approved corrective action plan is a result of the blister packaging not being child-resistant and so being deemed to pose a risk of harm in cases where a child may swallow the medicine. Only Zofran and Entresto medicines packaged in blister packs are affected, those in bottles are not being impacted.

Originally, the blister packs had been developed for sole use in institutions (such as hospitals). However, it has come to the attention of the company that some of these packs were sent to retail pharmacies, which indicates they may have been dispensed for home use.

A full list of affected medicines can be found on Novartis’ website. Anyone who has a pack listed on the company’s website are being advised to call the company and order a child-resistant pouch to store the blister packs.