Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning
CPSC recall 20091. Recall date: .
Hazard, in the words of CPSC
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.
Remedy, in the words of CPSC
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.
CPSC recall 20091 has the recall date 18 Mar 2020. The notice names the firm Novartis Pharmaceuticals. The recall has about 73,000 units. The median CPSC recall of 2020 has 6,100 units. This register puts the recall under the hazard Poisoning.
Federal law prohibits any person from selling products subject to a Commission ordered recall or a voluntary recall undertaken in consultation with the CPSC.
CPSC publishes these words. Source: CPSC recall notices, section About the U.S. CPSC, read on . The hazard, the remedy and the incident text on this site are the words of the CPSC recall notice. Newest CPSC recall on the register: .
More of the notice
The hazard and the remedy are at the top of the page. Each quotation is the text of CPSC.
| Incidents and injuries | None reported. |
|---|---|
| Units | 73,000 |
| Remedy options | New Instructions, Repair |
| Description | 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 |
| 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, About 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. |
| Distributor | Novartis Pharmaceuticals Corporation |
| Made in | United States |
Recall notice: The page that CPSC publishes for one recall of a consumer product. It states the product, the hazard, the remedy and the incidents.
Hazard: The way a product can cause harm, in the words of the CPSC recall notice. This site also puts each recall under short hazard names.
Remedy: What the manufacturer or the firm does about a recalled product. The agency record states the remedy of each recall.
Units: The number of vehicles or products that a recall can include. The manufacturer or the firm reports the number to the agency.
The recall in context
- Units in this recall
- 73,000Median of 2020: 6,100
- CPSC recalls of 2020
- 257
- Recalls of 2020 with one of the same hazards
- 22%
- Recalls on the register that name Novartis Pharmaceuticals
- 1
Official channels
- CPSC recall notice 20091The notice on the CPSC site, with the pictures and the contact of the firm.
- CPSC recallsThe list of all recall notices on the CPSC site.
- SaferProducts.govThe CPSC site for a report about a consumer product.
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Cite this page
Recall Register. CPSC recall 20091. https://recallregister.com/product/8767-novartis-recalls-100-mg-sandimmune-and-neoral-prescription-drug-bliste/. Source: CPSC Recall Retrieval Web Services. Data through .
Sources
- Source
- US Consumer Product Safety Commission
- Licence
- US government work, public domain
- Data retrieved
- 30 Sep 2026
- Newest CPSC recall on the register
- 24 Sep 2026
The CPSC notice is the authority. The hazard names come from the hazard text of CPSC. The category is the product type that CPSC gives. How the register is made. Report an error.
Questions
- Does CPSC recall 20091 report injuries?
- The CPSC notice says:
None reported.
- Where was the product sold?
- The CPSC notice says:
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.
- Which remedy options does CPSC list for recall 20091?
- CPSC lists 2 remedy options:
New Instructions, Repair
- How many units are in CPSC recall 20091?
- The CPSC notice gives this number:
About 73,000