CPSC official recall · 20091

Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning

召回日期：2020-03-18官方最后发布：2020-03-18适用地区：美国

重要：以下安全事实保留 CPSC 官方英文原文，避免翻译改变含义。请通过右侧官方公告确认行动要求。

危险说明 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.

受影响产品

Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages

Units：About 73,000

官方描述 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

事故与伤害 Incidents / Injuries

None reported.

官方补救措施 Remedy

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.

Options：New Instructions · Repair

消费者联系信息

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.