Health Canada has announced that Pharmascience Inc. is recalling one lot of the heartburn medication PMS-Ranitidine (150mg strength tablets) after tests show it contained NDMA.
Last fall, NDMA was found in some ranitidine products, known by the brand name Zantac. Numerous Zantac recalls followed in both Canada and the United States. Both countries launched investigations into the cause of the impurity.
What is NDMA?
NDMA is short for N-Nitrosodimethylamine. Medical experts believe this chemical is likely to increase a person’s chances of developing cancer.
NDMA is a known environmental contaminant present in water and foods such as meats and dairy products. Regulations consider consuming up to 96 nanograms of NDMA per day to be reasonably safe for humans based on lifetime exposure. However, sustained higher levels may increase the risk of cancer.
Timeline of Zantac Recalls and Withdrawals
In September 2019, Health Canada ordered companies to temporarily stop distributing Zantac medication while the agency assessed the risk. The U.S. Food and Drug Administration (FDA) ordered Zantac makers selling products in the U.S. to test their drugs and recall any that had levels above 96 nanograms. Several recalls followed.
Beginning in January and February, Health Canada permitted some manufacturers to resume sales of their Zantac products. Before doing so, they were required to test every batch of the medication for NDMA before releasing it for sale, as well as throughout its shelf life.
While sales continued in the U.S., on April 1, the FDA called for the withdrawal of all Zantac products in the U.S. after further investigation found that levels of NDMA can increase to unsafe levels during certain situations, including normal storage conditions.
Health Canada, however, continues to sell — and recall — dozens of Zantac products.