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

  • Donepezil ODT 10 mg
  • Naratriptan 2.5 mg tablets
  • Ondansetron Tablets 8 mg.
  • Risperidone ODT 2 mg.
  • Zofran® ODT 4 mg.
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:
New Instructions
Recall Date:
July 06, 2018
Units:
About 470,000
Consumer Contact

Sandoz and Novartis toll-free at 888-669-6682 from Monday to Friday, 8:30 a.m. to 5 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

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 Prescription Drugs NDC Numbers Tablet Strength Carton Configuration Lot Numbers Expiration Date
Zofran ODT® 0078-0679-61

0078-0679-19

4 mg 30 count: 3 cards with 10 tablets each 1657088

 

Dec 2019

 

Zofran ODT® 0078-0680-61

0078-0680-19

8 mg 30 count: 3 cards with 10 tablets each 1641546

 

Oct 2019

 

Entresto® (sacubitril/valsartan) 0078-0659-61

0078-0659-35

24 mg/ 26 mg 100 count: 10 cards with 10 tablets each FX000005

FX000004

FX000003

F0010

F0009

F0007

Apr 2020

Apr 2020

Sep 2019

Nov 2018

Aug 2018

Jul 2018

Entresto® (sacubitril/valsartan) 0078-0777-61

0078-0777-35

49 mg/ 51 mg 100 count: 10 cards with 10 tablets each FX000001

F0006

F0005

F0004

Dec 2019

Oct 2019

Aug 2019

Oct 2018

Entresto® (sacubitril/valsartan) 0078-0696-61

0078-0696-35

97 mg/ 103 mg 100 count: 10 cards with 10 tablets each FX000002

F0007

F0006

F0005

F0004

Mar 2020

Feb 2020

Dec 2019

Dec 2018

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 Prescription Drugs Tablet Strength NDC Numbers Carton Configuration
Azithromycin Tablets 250 mg 0781-5776-06

0781-5776-69

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

0781-5276-64

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

0781-5277-64

30 count: 3 cards with 10 tablets each
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 Tablets 25 mg 0781-1764-13 100 count: 10 cards with 10 tablets each
Imipramine HCl Tablets 50 mg 0781-1766-13 100 count: 10 cards with 10 tablets each
Isosorbide Dinitrate (ISDN) Tablets 10 mg 0781-1556-13 100 count: 10 cards with 10 tablets each
Isosorbide Dinitrate (ISDN) Tablets 20 mg 0781-1695-13 100 count: 10 cards with 10 tablets each
Naratriptan Tablets 2.5 mg 0781-5527-06

0781-5527-37

9 count: 1 card with 9 tablets
Ondansetron Tablets 8 mg 0781-1681-33 3 count: 1 card with 3 tablets
Ondansetron ODT 4 mg 0781-5238-06

0781-5238-64

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

0781-5239-64

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

0781-5239-80

10 count: 1 card with 10 tablets
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

0781-5310-08

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

0781-5311-08

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

0781-5312-08

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

0781-5313-08

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

0781-5314-08

28 count: 7 cards with 4 tablets each
Remedy:

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.

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.

Manufactured In:
Croatia, India, Ireland, Israel, Italy, Singapore, Spain, UK and U.S.
Distributor(s):

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

Recall number:
18-183
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About the U.S. CPSC
The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually. CPSC’s work to ensure the safety of consumer products has 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 lifesaving information:
SaferProducts.gov