Le Lézard
Classified in: Health
Subjects: CHI, RCL

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


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

The U.S. Consumer Product Safety Commission is an independent federal agency created by Congress in 1973 and charged with protecting the American public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction. To report a dangerous product or a product-related injury, call the CPSC hotline at 1-800-638-2772, or visit http://www.saferproducts.gov. Further recall information is available at http://www.cpsc.gov. (PRNewsfoto/U.S. Consumer Product Safety Co)

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
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

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

SOURCE U.S. Consumer Product Safety Commission


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