| Product name |
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 |
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 include; Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules - NDC Numbers - 0078-0241-15 and 0078-0241-61 - Lot Numbers - APCA136, APCA339, APCA793, and APCC238. Expiration Date - (09/2020), (02/2021 01/2022), and (07/2022). Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules - NDC Numbers 0078-0248-15 and 0078-0248-61 - Lot Numbers - APCA437 and APCA979 - Expiration Dates (07/2020), and (03/2021). |
| Problem |
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. |
| Distribution |
Clinics and pharmacies nationwide as a prescribed medicine, at prices varying based on quantities prescribed, health insurance terms, and other factors. |
| Company |
Novartis toll-free 866-629-6182; web site www.pharma.us.novartis.com, https://www.pharma.us.novartis.com/news/statements/corrective-action-certain-100-mg-sandimmune-and-neoral-blister-packages-us |
| Dates sold |
March 2018 through March 2020 |
| Date posted |
03/18/2020 |
| Additional information |
For additional information, visit the U.S. Consumer Product Safety Commission's news release at 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 |
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