The Recall Desk
HighCPSC·20091·Announced 2020-03-18

Novartis Recalls 100 mg Sandimmune and Neoral Blister Packages for Packaging Defect

Novartis is recalling 100 mg Sandimmune and Neoral blister packages because they fail child-resistant packaging 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 (poisoning) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.

Plain-English summary

Novartis Pharmaceuticals Corporation is recalling approximately 73,000 units of Sandimmune (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules. The recall involves specific blister packages that do not meet the child-resistant packaging requirements of the Poison Prevention Packaging Act (PPPA).

The affected products were sold as prescribed medicines at clinics and pharmacies nationwide from March 2018 through March 2020. The specific NDC numbers, lot numbers, and expiration dates for the recalled items are listed in the official recall notice. The hazard is that the packaging is not child-resistant, which poses a risk of poisoning if the contents are swallowed by young children. No injuries have been reported.

Consumers should immediately secure the product out of the sight and reach of children. They should contact Novartis to request a free child-resistant pouch to store the blister package medications. Consumers can continue to use the medication as directed while using the child-resistant pouches until new child-resistant blister packaging is available.

The recalled product

Product
Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages
Category
Drug — Prescription Medication
Hazard
Affected units
73,000

Distribution

Distributed nationwide across the United States.

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