Products Liability Law Daily Sandimmune® and Neoral® blister-packs recalled for failure to meet child-resistant packaging standards
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Thursday, March 19, 2020

Sandimmune® and Neoral® blister-packs recalled for failure to meet child-resistant packaging standards

By Georgia D. Koutouzos, J.D.

A poisoning risk is posed if these immunosuppressant drugs are swallowed by young children.

Pharmaceutical manufacturer Novartis Corporation is recalling about 73,000 units of the prescription cyclosporine medications Sandimmune® and Neoral® because the products’ blister packaging is not child-resistant as required by the Poison Prevention Packaging Act (PPPA) and the packages pose a risk of poisoning if the contents are swallowed by young children (CPSC Recall Notice, No. 20-091, March 18, 2020).

Incidents and injuries. No incidents or injuries have been reported.

Product description. The recall covers blister packages of prescription medications Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules. Packages of Sandimmune 100 mg contain three blister cards with ten soft gelatin capsules per card, while packages of Neoral 100 mg contain five blister cards with six soft gelatin capsules per card.

The recalled blister packages have "Novartis," the name of the medication, dosage, NDC, lot number and expiration date on the outer package and on the blister cards. Only 100 mg doses of these medications with the following NDC and lot numbers and expiration dates are included in the recall:

  • Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules, NDC No. 0078-0241-15 (Lot No. APCA136), expiration date 09/2020;
  • Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules, NDC No. 0078-0241-61 (Lot Nos. APCA339, APCA793, and APCC238), expiration date 02/2021, 01/2022, and 07/22;
  • Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules, NDC No. 0078-0248-15 (Lot No. APCA437), expiration date 07/2020; and
  • Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules, NDC No. 0078-0248-61 (Lot No. APCA979), expiration date 03/2021.

Remedy. Consumers should secure the products out of the sight and reach of children immediately and should contact Novartis to request a free child-resistant pouch in which to store the blister-package medications. Consumers can continue to use the medications as directed, but the child-resistant pouches should be used to store the products until new child-resistant blister packaging is available.

Customer contact. For more information, customers can contact Novartis toll-free at 866-629-6182 from 8 a.m. to 8 p.m. ET daily; by email at [email protected]; or online at www.pharma.us.novartis.com (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.

Companies: Novartis Pharmaceuticals Corp.

MainStory: TopStory RecallNewsStory DrugsNews GCNNews

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