Sandoz & Novartis Drug Blister Package Recall [US]


US FlagUS/Washington: Sandoz and Novartis Drug Blister Package Recall [US]Sandoz and Novartis recall an estimated 470,000 Prescription Drug Blister Packages due to suspected failure to meet child-resistant closure requirements as required by the US Poison Prevention Packaging Act and consequential risk of choking, ingestion and poisoning, all serious health and safety hazards.

CPSC: http://ht.ly/qXyk30kR2SM

Direct link: https://www.cpsc.gov/Recalls/2018/Sandoz-and-Novartis-Recall-Prescription-Drug-Blister-Packages-Due-to-Failure-to-Meet-Child-Resistant-Closure-Requirements

Additional information:
The US Consumer Product Safety Commission (“CPSC”) reports this recall involves certain Blister Packages of various Prescription Drugs branded by Novartis and Sandoz. The Drugs are packaged with three (3) to ten (10) tablets per blister card.

  • The recalled Novartis Prescription Blister Packages have the manufacturer, “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:
    • Entresto (Sacubitril/Valsartan), sold with NTCs of 0078-0659-61 and 0078-0659-35
    • Entresto (Sacubitril/Valsartan), sold with NTCs of 0078-0696-61 and 0078-0696-35
    • Entresto (Sacubitril/Valsartan), sold with NTCs of 0078-0777-61 and 0078-0777-35
    • Zofran ODT, sold with a DIN of 0078-0680-61 and 0078-0680-19
    • Zofran ODT, sold with NTCs of 0078-0679-61 and 0078-0679-19
  • The recalled Sandoz prescription blister packages have the brand, “Sandoz”, the name of the drug, dosage, NDC and lot number printed on the cartons and the blister cards. Lot numbers are listed at http://www.us.sandoz.com/patients-customers/product-safety-notices
    • Azithromycin Tablets, sold with NTCs of 0781-5776-06 and 0781-5776-69
    • Donepezil ODT  Tablets, sold with NTCs of 0781-5276-06 and 0781-5276-64
    • Donepezil ODT Tablets, sold with NTCs of 0781-5277-06 and 0781-5277-64
    • Haloperidol Tablets, sold with an NTC of 0781-1391-13
    • Haloperidol Tablets, sold with an NTC of 0781-1392-13
    • Haloperidol Tablets, sold with an NTC of 0781-1393-13
    • Haloperidol Tablets, sold with an NTC of 0781-1396-13
    • Haloperidol Tablets, sold with an NTC of 0781-1397-13
    • Imipramine HCl Tablets, sold with an NTC of 0781-1764-13
    • Imipramine HCl Tablets, sold with an NTC of 0781-1766-13
    • Isosandbide Dinitrate (“ISDN”) Tablets, sold with an NTC of 0781-1556-13
    • Isosandbide Dinitrate (“ISDN”) Tablets, sold with an NTC of 0781-1695-13
    • Naratriptan Tablets, sold with NTCs of 0781-5527-06 and 0781-5527-37
    • Ondansetron ODT, sold with NTCs of 0781-5239-06 and 0781-5239-64
    • Ondansetron ODT, sold with NTCs of 0781-5239-06 and 0781-5239-80
    • Ondansetron ODT, sold with NTCs of 0781-5238-06 and 0781-5238-64
    • Ondansetron Tablets, sold with an NTC of 0781-1681-33
    • Perphenazine Tablets, sold with an NTC of 0781-1047-13
    • Perphenazine Tablets, sold with NTCs of 0781-1046-13
    • Perphenazine Tablets, sold with NTCs of 0781-1048-13
    • Risperidone ODT, sold with an NTC of 0781-5313-06 and 0781-5313-08
    • Risperidone ODT, sold with an NTC of 0781-5314-06 and 0781-5314-08
    • Risperidone ODT, sold with NTC of 0781-5312-06 and 0781-5312-08
    • Risperidone ODT, sold with NTCs of 0781-5310-06 and 0781-5310-08
    • Risperidone ODT, sold with NTCs of 0781-5311-06 and 0781-5311-08

Please consult the photograph above for details of the product’s packaging, design and retail presentation. Additional images of the recalled drugs can be found on the Web sites listed above.

According to the CPSC, the prescription drug packaging is not child resistant as required by the US Poison Prevention Packaging Act, posing both ingestion and poisoning risks if swallowed by children. The firms have received one (1) report of a child ingesting Haloperidol from a Blister Pack.

If you believe you have purchased or have in your possession any of the recalled Prescription Drug Blister Packages, please do not use them. Instead, you 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 you can continue to use your medication as directed once the Blister packages are secured.

If you have any questions about this recall notification, please contact Sandoz and Novartis toll-free at 1-888-669-6682 from 8:00 AM to 8:00 PM, Eastern Standard Time, Monday to Friday and from 9:00 AM to 8:00 PM, EST on Saturday and Sunday.

You can also reach the companies on the Web at http://www.us.sandoz.com and click on the “Patients and Customers” link then on “Product Safety Notices”, or at http://www.pharma.us.novartis.com and click on the banner “Novartis recalls select product blister packs.online” at http://www.us.sandoz.com and click on “Patients and Customers” then “Product Safety Notices”, or at http://www.pharma.us.novartis.com and click on the banner “Novartis recalls select product blister packs”.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Drugs or Medications, please search for “drug” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Ingestion hazards, please search for “ingestion” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to products made, marketed and/or sold by Novartis, please search for “Novartis” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to products made, marketed and/or sold by Sandoz, please search for “Sandoz” using the Search Box at the top of this page.

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More information about this recall:
CPSC recall number: 18-183
Recalls Direct RIN: 10373-2018
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in the United States [external: new window opens]:
==> https://www.saferproducts.gov/CPSRMSPublic/Incidents/ReportIncident.aspx
Search for a recalled product on the US CPSC Web site [external: new window opens]:
==> https://www.cpsc.gov/Recalls/

We welcome your feedback:
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E. & O. E.

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