Heartburn medicine recalled amid concerns it contains traces of cancer-causing chemical

The health product watchdog has issued a recall of a heartburn medicine amid concerns it contains traces of a cancer-causing chemical.

The Health Products Regulatory Authority has issued a recall notice for Ranitidine medicines to pharmacies across the country after reports that batches of both brand and generic versions of the drug contained low-level impurities of a known carcinogen.

Brands affected include Ranitic, Gertax, and Zantac, though not all batches on the Irish market are subject to the Irish recall.

“The reason for the recall is that a nitrosamine impurity has been identified in ranitidine active substance batches manufactured at a manufacturing site in India,” the HPRA said.

“This impurity, N-nitrosodimethylamine (NDMA), is classified as a probable human carcinogen based on results from laboratory tests.

"It is a known environmental contaminant and found in water and foods,” it added.

The HPRA’s recall of Ranitidine in Ireland mirrors similar orders across the world.

The US’s Food and Drug Administration has also issued a recall.

“Ranitidine Hydrochloride tablet is an over the counter (OTC) oral product indicated for the relief of heartburn associated with acid indigestion and sour stomach and prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages,” the FDA said.

Despite the recall, the HPRA has told members of the public that they do not need to return the medicine to pharmacies.

It also said there is no evidence at this stage that the impurity has caused any harm to patients.

“This is a precautionary recall to pharmacy/retail level,” a spokesperson for the HPRA told the Irish Examiner.

“There is no recommendation for patients who have ranitidine to stop taking it.

"If a patient has any questions they should speak to their doctor or pharmacist.

"Patients may also consider that there are other medicines (including over-the-counter medicines) that can be used for the same conditions as ranitidine,” the HPRA advised.