Pharmascience Inc., is recalling one lot of the heartburn medication PMS-Ranitidine (150mg strength tablets) after tests show it contained NDMA, short for N-Nitrosodimethylamine, an impurity considered to be a probable carcinogen, Health Canada announced.
Last fall, NDMA was initially found in some ranitidine products, known by the brand name Zantac. Numerous Zantac product recalls followed in both Canada and the United States. Both countries launched investigations into the cause of the impurity.
NDMA is a known environmental contaminant found in water and foods such as meats and dairy products. Consuming up to 96 nanograms of NDMA per day is considered reasonably safe for humans based on lifetime exposure. But sustained higher levels may increase the risk of cancer in humans.
In September 2019, Health Canada ordered companies to temporarily stop distributing Zantac medication while the agency assessed the risk. And, 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 provided they 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.
Attorneys with Beasley Allen Law Firm are currently investigating claims of those who have used Zantac, which was voluntarily recalled from the market on Sept. 13, 2019, and withdrawn on April 1, and has been linked to certain types of cancer, including liver, bladder, stomach, colon, kidney and pancreatic cancer. If you or a loved one was a regular user of Zantac or any other product containing ranitidine and have been diagnosed with cancer, we would like to talk with you. Contact Frank Woodson, one of our leading pharmaceutical attorneys in charge of Zantac cancer claims.