Reported Mar 18, 2020

Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant…

Novartis Pharmaceuticals Corporation of East Hanover, N.J.

Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.

What you should do

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.

Firm 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.

What it looks like

  • Recalled product from Novartis Pharmaceuticals Corporation
  • Recalled product from Novartis Pharmaceuticals Corporation

Is this the product you have?

  • Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages
Amount recalled
About 73,000

Where it was sold

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..

Why it was recalled

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.

The agency has not ranked the risk yet — treat the notice as a caution.

Reports so far: None reported.

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Where this came from

Source: U.S. Consumer Product Safety Commission

Read the CPSC notice

Notice updated Mar 18, 2020 · Data as of Sep 19, 6:05 PM UTC

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