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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskCPSC
Medications & Supplements/Prescription Drugs

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

Agency Publication Date: March 18, 2020
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Summary

Novartis is recalling about 73,000 blister packages of Sandimmune (cyclosporine) 100 mg and Neoral (cyclosporine) 100 mg soft gelatin capsules. The drug packaging fails to meet child-resistant requirements, which could allow children to access and ingest the medication. These prescription drugs were sold at clinics and pharmacies nationwide between March 2018 and March 2020. Consumers can continue to use their medication as directed but must take immediate steps to secure it.

Risk

The packaging is not child-resistant, posing a serious risk of accidental poisoning if the capsules are swallowed by young children. No injuries or incidents have been reported to date.

What You Should Do

  1. Check your prescription packaging for Sandimmune 100 mg (NDC 0078-0241-15/61, lots APCA136, APCA339, APCA793, or APCC238) or Neoral 100 mg (NDC 0078-0248-15/61, lots APCA437 or APCA979).
  2. Immediately move the medication to a secure location that is completely out of the sight and reach of children.
  3. Contact Novartis at 866-629-6182 (8 a.m. to 8 p.m. ET daily) or email Novartis5060@stericycle.com to request a free child-resistant pouch for storing your blister cards.
  4. Continue taking your medication as prescribed, but keep the blister cards inside the child-resistant pouch until you receive new packaging from your pharmacy.
  5. Call the CPSC Hotline at 800-638-2772 if you have additional questions regarding this safety recall.

Your Remedy Options

📋New Instructions, Repair

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.

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.

Affected Products

Product: Sandimmune (cyclosporine capsules, USP) 100 mg soft gelatin capsules
Model:
0078-0241-15
0078-0241-61
Lot Numbers:
APCA136 (Exp 09/2020)
APCA339 (Exp 02/2021)
APCA793 (Exp 01/2022)
APCC238 (Exp 07/2022)
Date Ranges: 09/2020, 02/2021, 01/2022, 07/2022
Product: Neoral (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules
Model:
0078-0248-15
0078-0248-61
Lot Numbers:
APCA437 (Exp 07/2020)
APCA979 (Exp 03/2021)
Date Ranges: 07/2020, 03/2021

Product Images

Recalled Neoral® 100 mg soft gelatin capsules

Recalled Neoral® 100 mg soft gelatin capsules

Recalled Sandimmune® 100 mg soft gelatin capsules

Recalled Sandimmune® 100 mg soft gelatin capsules

Additional Information

Agency: Consumer Product Safety Commission (CPSC)
Recall ID: 20091
Status: Active
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.
Distributor: Novartis Pharmaceuticals Corporation, of East Hanover, N.J.
Manufactured In: United States
Units Affected: About 73,000
Distributed To: Nationwide
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.
Agency Last Updated: March 18, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: CPSC Notice · Raw API Response