Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements

Published: Jul 06, 2018

WASHINGTON, July 6, 2018 /PRNewswire-USNewswire/ -- https://www.cpsc.gov/Recalls/2018/Sandoz-and-Novartis-Recall-Prescription-Drug-Blister-Packages-Due-to-Failure-to-Meet-Child-Resistant-Closure-Requirements

Recall Summary

Name of Product: Blister packages of prescription medication

Hazard: The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.

Remedy: Instructions, Notice

Consumers should immediately secure the blister cards to keep them out of the sight and reach of children and contact Novartis or Sandoz for further instructions. Novartis and Sandoz advise that consumers should continue to use the medication as directed once the blister packages are secured.

Consumer Contact: Sandoz and Novartis toll-free at 888-669-6682 from Monday to Friday, 8 a.m. to 8 p.m. ET and Saturday and Sunday, 9 a.m. to 6 p.m. ET or online at www.us.sandoz.com and click on "Patients and Customers" then "Product Safety Notices," or at www.pharma.us.novartis.com and click on banner "Novartis recalls select product blister packs."

Recall Details

Units: About 470,000

Description: This recall involves blister packages of prescription drugs from Novartis and Sandoz. The drugs are packaged with 3 to 10 tablets per blister card.

The recalled Novartis prescription blister packages have "Novartis," the name of the drug, dosage, NDC, lot number and expiration date printed on the cartons and the blister cards. The recall includes the following:

    Recalled Novartis NDC          Tablet   Carton        Lot              Expiration
    Prescription
     Drugs            Numbers      Strength Configuration Numbers          Date
    ------------      -------      -------- ------------- -------          ----

    Zofran ODT(R)     0078-0679-61 4 mg     30 count: 3            1657088  Dec 2019
                                            cards with 10
                      0078-0679-19          tablets each
    ---               ------------          ------------

    Zofran ODT(R)     0078-0680-61 8 mg     30 count: 3            1641546  Oct 2019
                                            cards with 10
                      0078-0680-19          tablets each
    ---               ------------          ------------

    Entresto(R)
     (sacubitril/
     valsartan)       0078-0659-61 24 mg/   100 count: 10 FX000005         Apr 2020
                                   26 mg    cards with 10
                      0078-0659-35          tablets each  FX000004         Apr 2020

                                                          FX000003         Sep 2019

                                                          F0010            Nov 2018

                                                          F0009            Aug 2018

                                                          F0007            Jul 2018
    ---                                                   -----            --------

    Entresto(R)
     (sacubitril/
     valsartan)       0078-0777-61 49 mg/   100 count: 10 FX000001         Dec 2019
                                   51 mg    cards with 10
                      0078-0777-35          tablets each  F0006            Oct 2019

                                                          F0005            Aug 2019

                                                          F0004            Oct 2018
    ---                                                   -----            --------

    Entresto(R)
     (sacubitril/
     valsartan)       0078-0696-61 97 mg/   100 count: 10 FX000002         Mar 2020
                                   103 mg   cards with 10
                      0078-0696-35          tablets each  F0007            Feb 2020

                                                          F0006            Dec 2019

                                                          F0005            Dec 2018

                                                          F0004            Oct 2018
    ---                                                   -----            --------

The recalled Sandoz prescription blister packages have "Sandoz," the name of the drug, dosage, NDC and lot number printed on the cartons and the blister cards.

Lot numbers are listed at www.us.sandoz.com/patients-customers/product-safety-notices.

The recall includes the following:

    Recalled Sandoz             Tablet   NDC          Carton
    Prescription Drugs          Strength Numbers      Configuration
    ------------------          -------- -------      -------------

    Azithromycin Tablets        250 mg   0781-5776-06 50 count: 5 cards with
                                                      10 tablets each
                                         0781-5776-69
    ---                                  ------------

    Donepezil ODT               5 mg     0781-5276-06 30 count: 3 cards with
    Tablets                                           10 tablets each
                                         0781-5276-64
    ---                                  ------------

    Donepezil ODT               10 mg    0781-5277-06 30 count: 3 cards with
    Tablets                                           10 tablets each
                                         0781-5277-64
    ---                                  ------------

    Haloperidol Tablets         0.5 mg   0781-1391-13 100 count: 10 cards
                                                      with 10 tablets each
    ---                                               --------------------

    Haloperidol Tablets         1 mg     0781-1392-13 100 count: 10 cards
                                                      with 10 tablets each
    ---                                               --------------------

    Haloperidol Tablets         2 mg     0781-1393-13 100 count: 10 cards
                                                      with 10 tablets each
    ---                                               --------------------

    Haloperidol Tablets         5 mg     0781-1396-13 100 count: 10 cards
                                                      with 10 tablets each
    ---                                               --------------------

    Haloperidol Tablets         10 mg    0781-1397-13 100 count: 10 cards
                                                      with 10 tablets each
    ---                                               --------------------

    Imipramine HCl              25 mg    0781-1764-13 100 count: 10 cards
    Tablets                                           with 10 tablets each
    -------                                           --------------------

    Imipramine HCl              50 mg    0781-1766-13 100 count: 10 cards
    Tablets                                           with 10 tablets each
    -------                                           --------------------

    Isosorbide Dinitrate (ISDN)
     Tablets                    10 mg    0781-1556-13 100 count: 10 cards
                                                      with 10 tablets each
    ---                                               --------------------

    Isosorbide Dinitrate        20 mg    0781-1695-13 100 count: 10 cards
    (ISDN) Tablets                                    with 10 tablets each
    --------------                                    --------------------

    Naratriptan Tablets         2.5 mg   0781-5527-06 9 count: 1 card with 9
                                                      tablets
                                         0781-5527-37
    ---                                  ------------

    Ondansetron Tablets         8 mg     0781-1681-33 3 count: 1 card with 3
                                                      tablets
    ---                                               -------

    Ondansetron ODT             4 mg     0781-5238-06 30 count: 3 cards with
                                                      10 tablets each
                                         0781-5238-64
    ---                                  ------------

    Ondansetron ODT             8 mg     0781-5239-06 30 count: 3 cards with
                                                      10 tablets each
                                         0781-5239-64
    ---                                  ------------

    Ondansetron ODT             8 mg     0781-5239-06 10 count: 1 card with
                                                      10 tablets
                                         0781-5239-80
    ---                                  ------------

    Perphenazine Tablets        2 mg     0781-1046-13 100 count: 10 cards
                                                      with 10 tablets each
    ---                                               --------------------

    Perphenazine Tablets        4 mg     0781-1047-13 100 count: 10 cards
                                                      with 10 tablets each
    ---                                               --------------------

    Perphenazine Tablets        8 mg     0781-1048-13 100 count: 10 cards
                                                      with 10 tablets each
    ---                                               --------------------

    Risperidone ODT             0.5 mg   0781-5310-06 28 count: 7 cards with
                                                      4 tablets each
                                         0781-5310-08
    ---                                  ------------

    Risperidone ODT             1 mg     0781-5311-06 28 count: 7 cards with
                                                      4 tablets each
                                         0781-5311-08
    ---                                  ------------

    Risperidone ODT             2 mg     0781-5312-06 28 count: 7 cards with
                                                      4 tablets each
                                         0781-5312-08
    ---                                  ------------

    Risperidone ODT             3 mg     0781-5313-06 28 count: 7 cards with
                                                      4 tablets each
                                         0781-5313-08
    ---                                  ------------

    Risperidone ODT             4 mg     0781-5314-06 28 count: 7 cards with
                                                      4 tablets each
                                         0781-5314-08
    ---                                  ------------

Incidents/Injuries: The firms have received one report of a child ingesting haloperidol from a blister pack.

Sold At: Clinics and pharmacies nationwide as a prescribed medicine from September 2016 to June 2018, at prices varying based on quantities prescribed, health insurance terms and other factors.

Distributor:
Sandoz Inc., of Princeton, N.J. and Novartis Pharmaceuticals Corp., of East Hanover, N.J.

Manufactured in:
Croatia, India, Ireland, Israel, Italy, Singapore, Spain, UK and U.S.

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

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SOURCE U.S. Consumer Product Safety Commission

 

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