CPSC2020-03-18
Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning
Novartis Pharmaceuticals Corporation, of East Hanover, N.J.
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.
Remedy
Consumers should immediately secure the product out of the sight and reach of children and contact the firm to request a free child-resistant pouch in which to store the blister package medications. Consumers can continue to use the medication as directed. The child-resistant pouches should be used to store these medications until new child-resistant blister packaging is available.
Sold at
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.
Affected count
About 73,000
Injuries reported
None reported.
Manufactured in
United States
Remedy type
New Instructions
Products
Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages
Consumer contact
Novartis toll-free at 866-629-6182 from 8 a.m. to 8 p.m. ET daily, email at Novartis5060@stericycle.com 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.
Official notice
https://www.cpsc.gov/Recalls/2020/Novartis-Recalls-100-mg-Sandimmune-and-Neoral-Prescription-Drug-Blister-Packages-Due-to-Failure-to-Meet-ChildResistant-Packaging-Requirement-Risk-of-PoisoningDon't want to check this manually?
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