Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning
Recall at a glance
- Recall number
- 20-091 (CPSC)
- Recall date
- March 18, 2020
- Brand
- Novartis
- Category
- Other consumer products
- Products
- Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages
- Hazard
- Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning
- Hazard type
- Choking and ingestionPoisoning and toxic substances
- Remedy
- New Instructions, Repair
- Units
- About 73,000
- Made in
- United States
- Last updated by CPSC
- March 18, 2020
What was recalled
This recall involves 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 from Novartis. Packages of Sandimmune 100 mg contain three blister cards with ten soft gelatin capsules per card and 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 this recall: Recalled Prescription Drugs NDC Numbers Lot Numbers Expiration Date Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules 0078-0241-15 0078-0241-61 APCA136 APCA339 APCA793 APCC238 09/2020 02/2021 01/2022 07/2022 Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules 0078-0248-15 0078-0248-61 APCA437 APCA979 07/2020 03/2021
Is my product affected?
Compare your product with the details below, including model numbers where listed.
- Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages · About 73,000 units
Photos from the recall notice
Where it was sold
Companies named in the notice: 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.; Novartis Pharmaceuticals Corporation, of East Hanover, N.J..
Consumer 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.
Recall history and context
Since 2019 CPSC has recorded 399 recalls in the other consumer products category, 68 recalls of them in the past 12 months.
Frequently asked questions
What was recalled?
Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages (About 73,000 units). This recall involves 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 from Novartis.
Why was it recalled?
CPSC lists the reason as: Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning.
What should I do if I own one?
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.
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Source: U.S. Consumer Product Safety Commission recall data, shown as published and last updated by CPSC on March 18, 2020. Details can change; the official notice is the authority. If your product may be recalled, stop and read the notice before deciding what to do. Terms and disclaimer.