More ranitidine heartburn products being recalled

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 Lte, Sanis Health Inc.and Sivem Pharmaceuticals, are recallingranitidine drugs. It iscommonly known by thebrand 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 asgastroesophageal reflux disease or GERD, Health Canada said.

Last week, regulators in Canada, the United Statesand Europe reported the presence of an impurity called N-nitrosodimethylamine (NDMA), in low levels in ranitidineproducts.

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 NDMAabove 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 theproducts will be pulled off store shelves.

In addition to the companies' recalls, Health Canada said it hasasked the companies to stop distributingranitidine drugs in Canada temporarily while it assessesNDMA.

Last year, NDMAwas one of the impurities found in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers.