Recall Date: March 18, 2020
Recall Number: 20-091
Recall Summary
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
Hazard: 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: New Instructions, Repair. 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.
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.
Pictures available here: https://www.cpsc.gov/Recalls/2020/Novartis-Recalls-100-mg-Sandimmune-and-Neoral-Prescription-Drug-Blister-Packages-Due-to-Failure-to-Meet-ChildResistant-Packaging-Requirement-Risk-of-Poisoning
Recall Details
Units: About 73,000
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 |
Incidents/Injuries: None reported.
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(s): Novartis Pharmaceuticals Corporation, of East Hanover, N.J.
Manufactured In: United States
