Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning

Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages

Date of Recall
2020-03-18

CPSC Release Number
20-091

Manufactured In
United States

Units
About 73,000

Distributor
Novartis Pharmaceuticals Corporation, of East Hanover, N.J.

Sold By
Clinics and pharmacies nationwide as a prescribed medicine from March 2018 through March 2020, at prices varying based on quantities prescribed, health insurance terms, and other factors.

Problem/Hazard
The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act (PPPA), posing a risk of poisoning if the contents are swallowed by young children.

Injuries/Incidents
None reported.

Description

 

Remedy
New Instructions

Consumer Contact
Novartis toll-free at 866-629-6182 from 8 a.m. to 8 p.m. ET daily, email at [email protected] or online at www.pharma.us.novartis.com and in the top navigation of the page go to the News tab and click on Statements, or visit https://www.pharma.us.novartis.com/news/statements/corrective-action-certain-100-mg-sandimmune-and-neoral-blister-packages-us for more information.

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