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Sandoz and Novartis Recall Prescriptions Drugs, Packaging Fails to Federal Requirements


Prescription medication bottles with multiple pills of various colors

The Consumer Product Safety Commission (CPSC) has announced the recall of about 74,000 units of drug packages because of a failure to meet closure requirements for child safety.

About the Recalled Drugs

Blister packages of prescription drugs manufactured by Sandoz and Novartis have been recalled. These packages contain between three and ten tablets.

There has been one reported incident of a child ingesting haloperidol from a blister package.

The issue can be remedied by immediately storing the blistering packages out of reach of children. Contents can be consumed after placing in secure area.

Drugs Included in the Recall

74,000 units from Novartis and Sandoz have been recalled.

The following units were manufactured with Novartis:

Recalled Novartis Prescription DrugsNDC NumbersTablet StrengthCarton ConfigurationLot NumbersExpiration Date
Zofran ODT®0078-0679-61

0078-0679-19

4 mg30 count: 3 cards with 10 tablets each1657088

 

Dec 2019

 

Zofran ODT®0078-0680-61

0078-0680-19

8 mg30 count: 3 cards with 10 tablets each1641546

 

Oct 2019

 

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

0078-0659-35

24 mg/ 26 mg100 count: 10 cards with 10 tablets eachFX000005

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 mg100 count: 10 cards with 10 tablets eachFX000001

F0006

F0005

F0004

Dec 2019

Oct 2019

Aug 2019

Oct 2018

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

0078-0696-35

97 mg/ 103 mg100 count: 10 cards with 10 tablets eachFX000002

F0007

F0006

F0005

F0004

Mar 2020

Feb 2020

Dec 2019

Dec 2018

Oct 2018

 

The following unites were manufactured with Sandoz:

Recalled Sandoz Prescription DrugsTablet StrengthNDC NumbersCarton Configuration
Azithromycin Tablets250 mg0781-5776-06

0781-5776-69

50 count: 5 cards with 10 tablets each
Donepezil ODT  Tablets5 mg0781-5276-06

0781-5276-64

30 count: 3 cards with 10 tablets each
Donepezil ODT Tablets10 mg0781-5277-06

0781-5277-64

30 count: 3 cards with 10 tablets each
Haloperidol Tablets0.5 mg0781-1391-13100 count: 10 cards with 10 tablets each
Haloperidol Tablets1 mg0781-1392-13100 count: 10 cards with 10 tablets each
Haloperidol Tablets2 mg0781-1393-13100 count: 10 cards with 10 tablets each
Haloperidol Tablets5 mg0781-1396-13100 count: 10 cards with 10 tablets each
Haloperidol Tablets10 mg0781-1397-13100 count: 10 cards with 10 tablets each
Imipramine HCl Tablets25 mg0781-1764-13100 count: 10 cards with 10 tablets each
Imipramine HCl Tablets50 mg0781-1766-13100 count: 10 cards with 10 tablets each
Isosorbide Dinitrate (ISDN) Tablets10 mg0781-1556-13100 count: 10 cards with 10 tablets each
Isosorbide Dinitrate (ISDN) Tablets20 mg0781-1695-13100 count: 10 cards with 10 tablets each
Naratriptan Tablets2.5 mg0781-5527-06

0781-5527-37

9 count: 1 card with 9 tablets
Ondansetron Tablets8 mg0781-1681-333 count: 1 card with 3 tablets
Ondansetron ODT4 mg0781-5238-06

0781-5238-64

30 count: 3 cards with 10 tablets each
Ondansetron ODT8 mg0781-5239-06

0781-5239-64

30 count: 3 cards with 10 tablets each
Ondansetron ODT8 mg0781-5239-06

0781-5239-80

10 count: 1 card with 10 tablets
Perphenazine Tablets2 mg0781-1046-13100 count: 10 cards with 10 tablets each
Perphenazine Tablets4 mg0781-1047-13100 count: 10 cards with 10 tablets each
Perphenazine Tablets8 mg0781-1048-13100 count: 10 cards with 10 tablets each
Risperidone ODT0.5 mg0781-5310-06

0781-5310-08

28 count: 7 cards with 4 tablets each
Risperidone ODT1 mg0781-5311-06

0781-5311-08

28 count: 7 cards with 4 tablets each
Risperidone ODT2 mg0781-5312-06

0781-5312-08

28 count: 7 cards with 4 tablets each
Risperidone ODT3 mg0781-5313-06

0781-5313-08

28 count: 7 cards with 4 tablets each
Risperidone ODT4 mg0781-5314-06

0781-5314-08

28 count: 7 cards with 4 tablets each

Contact an Experienced Liability Attorney

It is a parent’s worst nightmare to find their child has ingested a drug from which they should be protected. If the unthinkable occurs to your child, you need an experienced defective product lawyer to represent you and your child. At Thomas J. Henry, we will fight to get the compensation your child deserves for their injuries and to bring justice to negligent manufacturers. Our firm has represented children from across the United States who have been the victims of negligent pharmaceutical companies.

Our firm has offices in Corpus ChristiSan Antonio, and Houston, serving clients across Texas and nationwide. Contact our team of attorneys to receive a free case review. We’re available 24/7, nights and weekends.

Contact Us for a Free Case Review

info@tjhlaw.com

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