The US Food and Drug Administration (USFDA) on Wednesday announced that it is requesting that manufacturers withdraw all prescription and over-the-counter ranitidine drugs, commonly known as Zantac, from the market immediately.
This is the latest step in an ongoing investigation to determined the levels of a contaminant known as N-Nitrosodimethylamine (NDMA), noted the drug regulator.
The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher-than-normal temperatures, poses a risk to public health.
"As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the US," the regulator announced.
Due to the coronavirus pandemic, the FDA said don't return your medicines to a "drug take-back location," but rather follow disposal instructions in the medication guide or insert - or follow the FDA's recommended safe disposal steps on its website.
The contaminant, N-Nitrosodimethylamine or NDMA, is a probable human carcinogen and the FDA has been investigating levels of it in ranitidine since 2019. USFDA had in September 2019 sounded an alert on the presence of NDMA in Ranitidine.
It has advised companies not meeting the limits of NDMA in Rantidine to recall it. Indian companies like Dr Reddy's, Strides Pharma, Aurobindo Pharma have recalled Ranitidine.
Strides suspended sales of Ranitidine on September 27 and relaunched in the US markets on November 8. Other manufacturers of ranitidine include JB Chemicals.
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