Press Release
24 October 2019 - 2:54pm

The Ministry of Health and Social Development has issued a recall on all Ranitidine medication made by Apotex Corp, Sanoz Inc., Sanofi and GlaxoSmithKline.

Ranitidine medication is prescribed for the treatment of ulcers, reflux esophagitis, zollinger-ellison syndrome and other conditions. It is also used for the relief of heart burn associated with acid indigestion and sour stomach brought on by food or drink that irritates the stomach.

Chief of Drugs and Pharmaceutical Services, Mrs. Gracia Wheatley-Smith explained that the ministry is asking that the dispensing of these affected products be discontinued immediately and that they be placed in quarantine until contact is made with supplier(s) for further instructions.  Businesses such as supermarkets that may stock the ‘over the counter’ formulation should also check their supply, remove from shelves, discontinue the sales and contact their suppliers.

The United States Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and other regulators have also indicated that some ranitidine medicines, including brand and generic, contain a nitrosamine impurity which has been classified as a probable human carcinogen by the World Health Organization, called N-nitrosodimethylamine (NDMA).              

The Ministry of Health and Social Development is advising pregnant women to avoid taking this medication and consult their physician for alternative treatment to any heartburn experiences.

Consumers with questions regarding the recall can contact Apotex Corp at 1 (800) 706 5575 between 8:30 a.m. - 5:00 p.m. eastern standard time Monday through Friday.

Consumers with questions regarding the recall can contact Sandoz at 1 (800) 525 8747 between 8:30 a.m. to 5:00 p.m. Monday to Friday eastern standard time or visit www.us.sandoz.com for more information.

Businesses can also contact Sanofi to return any remaining stock. Contact Inman at 1(877) 275 0993 or email zantacrecall@inmar.com

Patients are asked to contact their physician if they may have experienced any problems related to taking this medicine and about alternative heartburn options. 

For more information, persons can also contact Chief of Drugs and Pharmaceuticals Services, Mrs. Gracia Wheatley-Smith at 468 4526 or 468 9850 or email her at: grwheatley-smith@gov.vg.

 

Notes:

The affected medicines are listed in the tables below:

PRODUCT LISTING OF COMPANIES

GlaxoSmithKline as Glaxo Welcome UK Ltd.

Product

PL Number

Zantac Syrup 150mg/10ml

10949/0108

Zantac Injection 50mg/2ml

10949/0109

Zantac Tablets 150mg

10949/0042

Zantaz Tablets 300mg

10949/0043

 

Sandoz Inc.

Product

NDC Number

Lot Number  

Expiration Date

Date of Manufacturer

Ranitidine 150mg Capsules 500 count

0781-2855-05

HD1862

4/30/2020

4/19/2017

Ranitidine 150mg capsules 500 count

0781-2855-05

HP9438

9/30/2020

9/5/2017

Ranitidine 150mg Capsules 500 count

0781-2855-05

HP9439

9/30/2020

9/6/2017

Ranitidine 150mg Capsules 500 count

0781-2855-05

HP9440

9/30/2020

9/5/2017

Ranitidine 150mg Capsules 60 count

0781-2855-60

HC9266

4/30/2020

4/19/2017

Ranitidine 150mg Capsules 60 count

0781-2855-60

HD1865

4/30/2020

9/6/2017

Ranitidine 150mg Capsules 60 count

0781-2855-60

HP9441

9/30/2020

8/7/2018

Ranitidine 150mg Capsules 60 count

0781-2855-60

JK7994

8/31/2021

8/7/2018

Ranitidine 150mg Capsules 60 count

0781-2855-60

JK8659

8/31/2021

8/7/2018

Ranitidine 150mg Capsules  30 count

0781-2865-31

HD8625

4/30/2020

4/27/2017

Ranitidine 150mg Capsules  30 count

0781-2865-31

HD9275

4/30/2020

4/27/2017

Ranitidine 150mg Capsules  30 count

0781-2865-31

HU2207

8/31/2020

8/24/2017

Ranitidine 150mg Capsules  30 count

0781-2865-31

HX6676

3/31/2021

3/20/2018

Ranitidine 150mg Capsules  30 count

0781-2865-31

HX6677

3/31/2021

3/20/2018

 

Apotex Corp.

Product

Strength

Pack Size

NDC Number

Ranitidine Tablets

150mg

50’s

11822-6052-1

Ranitidine Tablets

150mg

65’s

11822-6052-2

Ranitidine Tablets

150mg

95’s

11822-4727-3

Ranitidine Tablets

150mg

65’s

49035-117-06

Ranitidine Tablets

150mg

24’s

49035-100-00

Wal-Zan® 150 Ranitidine Tablets 150mg

150mg

200

0363-1030-07

Ranitidine Tablets                

150mg

24’s

11822-6051-8

Ranitidine Tablets

150mg

130s

49035-100-07

Wal-Zan® Ranitidine Tablets

150mg

24’s

0363-1013-02

Wal-Zan Ranitidine Tablets

75mg

30’s

0363-1029-03

Cool Mint Ranitidine Tablets

150mg

24’s

11822-6107-4

Wal-Zan® Ranitidine Tablets

150mg

65’s

0363-1030-06

Wal-Zan® Ranitidine Tablets

150mg

95’s

0363-1030-09

 

Author

Adrianna J. Soverall

Ag. Public Health Communications Specialist
Ministry of Health and Social Development
Telephone: 468-3701 ext. 852 7742
Email:    asoverall@gov.vg

 

Ministry or Department Associated with this News Article:

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