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.

Sandoz Inc.

Apotex Corp.