Mar 18, 2020   SOURCE: PR NewsWire

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

WASHINGTON, March 18, 2020 /PRNewswire/ -- https://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 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: Repair, New Instructions

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.

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 
     
             Expiration
                                                                     Numbers               Date


        Sandimmune(R)
         (cyclosporine
         capsules, USP) 100 mg
         soft gelatin capsules             
       0078-0241-15        
          APCA136               
            09/2020

                                           
       0078-0241-61        
          APCA339        
           02/2021 01/2022

                                                                   
          APCA793               
            07/2022

                                                                   
          APCC238

    ---

        Neoral(R)
         (cyclosporine
         capsules, USP)
         MODIFIED 100 mg soft
         gelatin capsules                  
       0078-0248-15        
          APCA437               
            07/2020

                                           
       0078-0248-61        
          APCA979               
            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: Novartis Pharmaceuticals Corporation, of East Hanover, N.J.

Manufactured in: United States

Footer
About U.S. CPSC:
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products under the agency's jurisdiction. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually. CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical or mechanical hazard. CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters and household chemicals - contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 40 years.

Federal law bars any person from selling products subject to a publicly-announced voluntary recall by a manufacturer or a mandatory recall ordered by the Commission.

For more lifesaving information, follow us on Facebook, Instagram @USCPSC and Twitter @USCPSC or sign up to receive our e-mail alerts. To report a dangerous product or a product-related injury go online to www.SaferProducts.gov or call CPSC's Hotline at 800-638-2772 or teletypewriter at 301-595-7054 for the hearing impaired.

CPSC Consumer Information Hotline
Contact us at this toll-free number if you have questions about a recall:
800-638-2772 (TTY 301-595-7054)
Times: 8 a.m. - 5:30 p.m. ET; Messages can be left anytime
Call to get product safety and other agency information and to report unsafe products.

Media Contact
Please use the phone numbers below for all media requests.
Phone: 301-504-7908
Spanish: 301-504-7800

Recall Number: 20-091

View original content to download multimedia:http://www.prnewswire.com/news-releases/novartis-recalls-100-mg-sandimmune-and-neoral-prescription-drug-blister-packages-due-to-failure-to-meet-child-resistant-packaging-requirement-risk-of-poisoning-301026491.html

SOURCE U.S. Consumer Product Safety Commission