Zofran, Entresto Recall Issued Over Risk of Child Poisoning Due to Unsafe Packaging

Amid concerns that certain blister packs used with Zofran, Entresto and 10 other prescription drugs do not meet federal child safety requirements, Novartis and Sandoz have issued a recall for about 470,000 drug packs. 

The U.S. Consumer Product Safety Commission (CPSC) announced the drug recall on July 6, after at least one report was received of a child who was able to ingest haloperidol from a defective blister pack.

The recall impacts certain versions of Zofran, Entresto, Azithromycin, Donepezil, Haloperidol, Imapramine, Inosorbide Dinitrate, Naratriptan, Ondansetron, Ondansetron ODT, Perphenazine and Risperdone.

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Federal safety officials warn that the drugs do not meet child resistant requirements, according to the Poison Prevention Packaging Act. Because a child can easily open the packaging and take the medication, it poses a poisoning risk to children.

The prescription drugs will have either “Sandoz” or “Novartis,” the name of the drug, dosage, NDC, and Lot number printed on the cartons and blister packs. The drugs are packaged with 3-10 pills per blister card.

The recall only affects drugs sold in blister packs, not pill bottles. It does not affect the drugs’ effectiveness and is only being recalled because the packaging is not child safety proof.

All of the affected drugs were sold nationwide at clinics and pharmacies from September 2016 to June 2018.

Consumers should immediately secure the drugs and make sure it is out of the reach of children. Consumers should continue to use the medication as long as it is secured from children.

Patient’s taking the medications can contact drugmakers Novartis or Sandoz for more information about the recall.

Side effects or adverse events can be reported to the FDA MedWatch Program.


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