The manufacturer of the popular heart burn remedy Zantac has voluntarily recalled its drug from stores in the United States and Canada while the FDA continues an investigation about a possible carcinogen in the drug.
“Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi has made the decision to conduct the voluntary recall in the U.S. and Canada as the investigation continues,” the company said in a statement.
A New Haven, Connecticut-based online pharmacy notified the FDA of its findings from testing that found Zantac and generic versions of the medications contained NDMA, or nitrosodimethylamine, a probable carcinogen in levels significantly higher than the FDA’s recommended daily limits. The FDA conducted its own testing which did not find the same levels previously reported, however their testing did reveal enough information to warrant further investigation. Preliminary FDA tests detected NDMA levels similar or slightly higher to amounts found in foods such as grilled and cured meats.
The FDA has not officially recommended people stop taking Zantac or its generic medications, however suggests people who want to discontinue prescribed versions of this drug contact their doctor or pharmacist. Over the counter and non-prescription consumers can simply substitute one of the many alternative drugs available to treat similar symptoms.
Apotex, the drug manufacturer of over-the counter ranitidine, said they are recalling the 75mg and 150mg dose tablets at three chain pharmacies due to possible low levels of NDMA.