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 Notice
Source: U.S. Consumer Product Safety Commission (CPSC) — official agency notice for recall CPSC-8767.
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
Corrective Action (per CPSC)
Source: U.S. Consumer Product Safety Commission (CPSC) — official agency notice for recall CPSC-8767.
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.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact 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. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the CPSC recall page.
- If you've been hurt by this product, report the incident to CPSC.
Consumer Contact (per CPSC)
Source: U.S. Consumer Product Safety Commission (CPSC) — official agency notice for recall CPSC-8767.
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.
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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. Recall FAQ
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. is the subject of a children's products recall: Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning. The notice was published on March 18, 2020 by the U.S. Consumer Product Safety Commission (CPSC). Approximately 73,000 units are potentially affected.