More lots of heartburn medication are under recall because they may have been manufactured with an ingredient that contains too much of an impurity, Health Canada said.
Four companies, Apotex Inc., Pro Doc Ltée, Sanis Health Inc. and Sivem Pharmaceuticals, are recalling ranitidine drugs. It is commonly known by the brand name Zantac.
Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid indigestion and sour stomach. The prescription versions are used to reduce stomach acid to prevent and treat conditions, such as heartburn and ulcers of the stomach and intestines, as well as gastroesophageal reflux disease or GERD, Health Canada said.
Last week, regulators in Canada, the United States and Europe reported the presence of an impurity called N-nitrosodimethylamine (NDMA), in low levels in ranitidine products.
NDMA is classified as a probable human carcinogen, meaning long-term exposure to levels above what is considered safe could increase the risk of cancer.
The recalled lots contain NDMA above accepted levels, Health Canada said.
Health Canada said it will update its list of affected products as needed.
The recall applies at the retail level, Apotex said in a release, meaning the products will be pulled off store shelves.
In addition to the companies’ recalls, Health Canada said it has asked the companies to stop distributing ranitidine drugs in Canada temporarily while it assesses NDMA.
Last year, NDMA was one of the impurities found in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers.