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Low-risk recall: A precautionary or labeling issue. Low risk, but worth knowing.

Novartis Pharmaceuticals Corporation 2020-03-18 Health safe CPSC
Health · CPSC · Recall #CPSC-20091

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

Issued March 18, 2020 · Novartis Pharmaceuticals Corporation · 73,000 units affected

In March 2020, Novartis Pharmaceuticals Corporation recalled the Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages, a low-risk health recall reported by the CPSC.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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.

What you should do

  1. 1 Stop using Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Novartis Pharmaceuticals Corporation to arrange your new instructions. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (New Instructions): 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.

Recall details

Brand
Novartis Pharmaceuticals Corporation
Category
Health
Recall date
March 18, 2020
Units affected
73,000
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.
Recall number
CPSC-20091
Made in
United States
Issuing agency
CPSC

In context

  • Novartis Pharmaceuticals Corporation has 2 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • 73,000 units is enough to reach roughly 1 in every 1,795 US households.
  • This is the 5th Health recall we've logged in 2020.
Read the official CPSC notice

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