The U.S. Food and Drug Administration has been investigating reports of contaminated Zantac and is asking pharmaceutical companies to voluntarily recall the drug pending an investigation of Zantac NDMA levels.

Zantac is the brand name for a type of medication known as ranitidine. Zantac and ranitidine are used to prevent and treat heartburn and stomach or intestinal ulcers.

Recently, reports have emerged from several countries that Zantac and other ranitidine brands may have been contaminated by an impurity called N-Nitrosodimethylamine (NDMA). Although NDMA is a common environmental contaminant, it is classified as a probable human carcinogen and should be avoided when possible due to its probable ability to cause cancer.

FDA Announces Investigation into Zantac NDMA Levels

According to an FDA announcement issued Nov. 1, several ranitidine products have been tested for NDMA so far.These products have contained levels of NDMA similar to the levels found in water and foods such as vegetables, dairy products, and grilled meats. While one exposure to NDMA is probably not harmful, the effects of NDMA build up over time and may cause cancer after enough exposures. As many people who take Zantac take it frequently, victims may have been exposed to this contaminant many times.

The FDA stated that although the tested Zantac NDMA levels were fairly low, these levels are still unacceptably high for FDA-approved medications. Due to the widespread contamination, the FDA has asked pharmaceutical companies to voluntarily recall their ranitidine products until it can be determined what is causing the contamination.

The FDA is still conducting the investigation into what is causing the NDMA Zantac contamination, and will continue to test ranitidine products to determine contaminant levels of various medications. Additionally, the administration is cautioning consumers who take over the counter ranitidine medications, and stated that testing done on alternative heartburn medications has not uncovered any NDMA contamination.

Prior to the FDA announcement requesting that companies recall their products due to the Zantac NDMA levels, drug companies Apotex and Sanofi had already recalled their ranitidine medications. Additionally, drugstore chains including CVS and Walgreens have pulled Zantac and generic brands from store shelves due to NDMA contamination concerns.

Who May Be Affected?

Approximately 15 million prescriptions for ranitidine medications are written each year in the United States. Due to the popularity of Zantac and generic ranitidine, thousands of people may have been affected by the NDMA contaminant in these medications.

If you have taken Zantac or other ranitidine drugs for the treatment of heartburn or ulcers, and believe you have consumed contaminated medication, you may benefit from a consultation with a products liability attorney. Victims who pursue class action lawsuits against drug manufacturers may be able to recover financial damages for medical expenses, injuries, pain and suffering, loss of income or earning capacity, and other costs, as well as punitive damages.