Product Recall Number: 20-091
Why was Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages 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.
Product Recall Number: 20-091
Product Safety Warning Number:
Date: 2020-03-18
Product Safety Warning Date:
Name Of Product: Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages
Description:
Hazard Description: 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.
Consumer Action: None Listed
Original Product Safety Warning Announcement: None Listed
Remedy Type: New Instructions, Repair
Units: About 73,000
Incidents: None reported.
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.
Importers: None Listed
Manufacturers: None Listed
Distributors: Novartis Pharmaceuticals Corporation, of East Hanover, N.J.
Manufactured In: United States
Custom Label: None Listed
Custom Field: None Listed