Several popular heartburn drugs have been recalled by pharmaceutical companies due to the presence of an impurity which may cause cancer.
A number of pharma firms have issued recalls on some of their heartburn drugs due to contamination with an impurity that may cause cancer. These medications have been contaminated with N-Nitrosodimethylamine, also known as NDMA.
The US Environmental Protection Agency (EPA) considers NDMA a possible carcinogen that can be unintentionally introduced into manufacturing through certain chemical reactions. Since 2018, the US Food and Drug Administration (FDA) has been investigating NDMA after it found the impurity in blood pressure and heart failure medicines known as ARBs.
This week, Denton Pharma Inc. recalled several batches of its ranitidine tablets, affecting all unexpired lots of 150 mg and 300 mg tablets distributed to Northwind Pharmaceuticals LLC and Crosswind Pharmacy. Meanwhile, Appco Pharma LLC also recalled 150 mg and 300 mg batches of its ranitidine hydrochloride capsules.
While no reports of people getting sick from these medications, the companies decided to recall them because they may be contaminated with NDMA.
Last year. several major retailers announced that they will stop selling ranitidine medications due to concerns that they may contain NDMA. Drug maker Novartis halted the distribution of all ranitidine medicines manufactured by Sandoz.
Dr. Reddy’s Laboratories Ltd. also recalled its ranitidine medicines while Sanofi recalled its popular heartburn medication Zantac OTC.
CVS has stopped selling Zantac and CVS Health brand ranitidine products, which are currently being examined for links to cancer. The US and the European Union are currently conducting investigations while Canada and France have announced the recall of Zantac.
On September 13, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) announced that they will be conducting an investigation after finding NDMA in drugs containing ranitidine.
The FDA has been trying to determine the cause of the problem and has been cooperating with international regulators to determine how the impurities are getting into these drugs.