The Recall Desk
HighCPSC·18183·Announced 2018-07-06

Sandoz and Novartis Recall Prescription Blister Packages for Child-Resistant Failure

Sandoz and Novartis are recalling about 470,000 blister packages of prescription drugs because the packaging failed to meet child-resistant closure requirements, posing a poisoning risk to children.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (prescription drugs) where injury has been reported (one child ingestion), but no deaths or serious injuries are stated, fitting the High severity criteria.

Plain-English summary

Sandoz and Novartis are recalling approximately 470,000 blister packages of prescription medications. The recall involves drugs from both manufacturers, including Zofran ODT, Entresto, Azithromycin, Donepezil ODT, Haloperidol, Imipramine HCl, Isosorbide Dinitrate, Naratriptan, Ondansetron, Perphenazine, and Risperidone ODT. The products were sold at clinics and pharmacies nationwide from September 2016 to June 2018.

The recall is being conducted because the blister packages failed to meet the child-resistant closure requirements mandated by the Poison Prevention Packaging Act. This defect poses a poisoning risk if the medication is swallowed by children. The firms have received one report of a child ingesting haloperidol from a blister pack.

Consumers should immediately secure the blister cards to keep them out of the sight and reach of children. They should contact Novartis or Sandoz for further instructions. The companies advise consumers to continue using the medication as directed once the blister packages are secured.

The recalled product

Product
Blister packages of prescription medication
Category
Drug — Prescription Medication
Hazard
Affected units
470,000

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · child poisoning

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