Recalls / 2020-03-18

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

20091 · Recalled 2020-03-18 · CPSC page

Recalled Neoral® 100 mg soft gelatin capsules

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

Hazards

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.

Reported injuries

None reported.

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.

Products

Name	Model	Units
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

Parties

Distributor: Novartis Pharmaceuticals Corporation, of East Hanover, N.J.
Made in: United States
Sold at: Clinics, pharmacies nationwide as a prescribed medicine, at prices varying based on quantities prescribed, health insurance terms, other factors.

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.

More images

Recalled Sandimmune® 100 mg soft gelatin capsules

Source: CPSC recall 20091. Inclusion in this database is not legal or medical advice.