TORONTO - Apotex Corp. issued a voluntary recall of ranitidine tablets, a generic form of Zantac meant to treat heartburn, over concerns that the tablets may contain too much of a probable human carcinogen.
The recall is precautionary and is in response to findings from the U.S. Food and Drug Administration (FDA) and other global regulators that some ranitidine medicines, including brand and generic formulations, contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).
Apotex has not received any reports of adverse events related to the use of its ranitidine products to date, according to an announcement from the FDA.
NDMA is a known environmental contaminant that is classified as a probable human carcinogen, meaning it could potentially cause cancer. It is found in water and foods, such as meat, dairy and vegetables.
Ranitidine Hydrochloride Tablet is an over the counter oral product used to treat and prevent heartburn.
Those concerned about a product they have bought and/or used can check with the FDA’s listing of affected products. The affected Ranitidine Hydrochloride Tablets can be identified by NDC numbers stated on the product label.
Affected tablets were distributed to warehousing chains nationwide, and Apotex Corp. has notified all its affected sellers of the recall and is arranging for return of all recalled product.