Novartis, in cooperation with the U.S. Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA), is voluntarily implementing a CPSC-approved corrective action plan for Zofran and Entresto product packages distributed in the United States. This action is not a result of any quality or safety concerns with the medications for their intended use.
The blister cards in which these products are packaged are not child-resistant, posing a risk of harm if the tablets are swallowed by children. Products in bottles are NOT impacted.
The complete list of cartos, blister packs, and lot numbers can be found on the Novartis website.
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These blister packs were developed solely for use in institutions (i.e., hospitals). However, we learned that some of these institutional packs were sent to retail pharmacies, indicating that they may have been dispensed for in-home use.
Anyone having the packages listed above should call Novartis at 888-NOW-NOVA (888-669-6682) from 8 a.m. to 8 p.m. ET Monday through Friday and 9 a.m. to 6 p.m. ET Saturday and Sunday to order a child-resistant pouch in which to store the blister packs within your possession.
The quality of these products has not been compromised, so patients should continue taking their medicine as directed by their physician. However, due to the risk of harm to children, immediately secure this medicine so that it is out of the sight and reach of children.