Glenmark Pharmaceutical Inc., USA voluntarily announced a recall of all unexpired lots of 150mg and 300mg ranitidine tablets on December 17, 2019. The lots were recalled because they potentially contained levels of N-nitrosodimethylamine (NDMA) above the U.S. Food and Drug Administration’s (FDA) acceptable daily intake levels.
Ranitidine product labels contain NDC numbers. The following NDCs of ranitidine tablets were recalled: 684620-248-60, 684620-248-01, 684620-248-05, 684620-249-30, 684620-249-01 and 684620-249-20.
NDMA has been classified by the U.S. Environmental Protection Agency (EPA) as a probable human carcinogen. It is extremely toxic to the liver and it can give rats liver fibrosis. Chronic exposure to low doses of NDMA has been known to give rats liver tumors. Scientists literally intentionally give rats NDMA to give them cancer for cancer research purposes. Exposure to NDMA can cause fever, headaches, vomiting and nausea. The normal function of organs like the liver, the kidneys and the lungs can also be affected by NDMA exposure.
A September 13, 2019 FDA safety alert announced that the FDA was aware that some ranitidine medications contain NDMA. The popular heartburn medication Zantac was mentioned as possibly containing NDMA. This announcement set off a wave of ranitidine recalls. Zantac was recalled in many forms. Many formulations of generic ranitidine have also been recalled. This Glenmark recall is just the latest in this series of ranitidine recalls.
Online pharmacy company Valisure tested ranitidine from multiple manufacturers across multiple dosage forms. Valisure said it found “extremely high levels of [NDMA] … in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.” Valisure detected over three million nanograms of NDMA per tablet. The FDA permits 96 nanograms of NDMA for daily intake.
Connecticut congresswoman Rosa DeLauro (D-CT) recently sent a letter to the U.S. Department of Health and Human Services (HHS) and the FDA urging them to pull all ranitidine drugs from the U.S. market.
“Due to a historically very high perception of safety, ranitidine is heavily prescribed to adults and infants and sold over-the-counter…. FDA’s failure to stop companies from selling ranitidine makes the United States government complicit in exposing infants and adults to the risk of cancer,” read the letter.
Valisure CEO David Light supported DeLauro’s request to the HHS and FDA.
“Scientific evidence strongly suggests that ranitidine is fundamentally unstable, is able to directly form the carcinogen NDMA and all products containing ranitidine possess a cancer risk,” said Light.