Denton Pharma, Inc. dba Northwind Pharmaceuticals issued a voluntary recall of all unexpired lots of 150mg and 300mg ranitidine tablets on Monday due to the presence or potential presence of the carcinogen N-nitrosodimethylamine (NDMA). Appco Pharma LLC followed suit one day later by voluntarily recalling all quantities and lots, within expiry, of ranitidine capsules for the same reason.
The following NDC numbers of Denton ranitidine were recalled: 70934-017-04, 70934-017-20, 70934-017-24, 70934-017-30, 70934-017-90, 70934-017-04, 70934-017-20, 70934-017-24, 70934-017-30, 70934-017-90.
The following batch numbers of Appco ranitidine were recalled: 1905227UE, 1905228UE, 1905225VN, 1905226VD, 1906295UN, 1906296UN, 1906297UN, 1906298UD.
Ranitidine is sold as Zantac and is a heartburn medication. These aren’t the only recent generic Zantac recalls. Glenmark Pharmaceutical, Inc., USA voluntarily recalled all unexpired lots of 150mg and 300mg tablets of ranitidine in December 2019. That recall was also due to the presence or potential presence of NDMA.
Testing laboratory Emery Pharma petitioned the U.S. Food and Drug Administration (FDA) in January 2020 to recall all ranitidine on the market. The lab said that unacceptably high levels of NDMA form in ranitidine when it is exposed to heat.
Connecticut congresswoman Rosa DeLauro (D-CT) sent a letter to the FDA and the U.S. Department of Health and Human Services (HHS) recently as well. The letter urged them to pull ranitidine from the market entirely.
“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,” the letter said.
The U.S. Environmental Protection Agency (EPA) classifies NDMA as a probable human carcinogen. It is very toxic to the liver. NDMA can give rats liver fibrosis. Chronic exposure to small doses of NDMA has been linked to liver tumors in rats. Researchers give rats NDMA so the rats develop cancer they can research. NDMA exposure can cause nausea, headaches, vomiting and fever. Organ function can be negatively affected by exposure to NDMA.
A September 2019 FDA safety alert announced the FDA’s awareness of ranitidine medications containing NDMA. A wave of ranitidine recalls followed this announcement. The Appco and Denton recalls are merely the latest in a long line of ranitidine recalls.