Ranitidine medications are mainly utilized to treat heartburn and stomach acidity and are available as prescription and over-the-counter drugs.
The health officials have detected impurity in the heartburn medicine Zantac which may lead to cancer, informed the FDA on Friday.
The Swiss drugmaker's decision follows an investigation by US and European regulators into the presence of the impurity, N-nitrosodimethylamine (NDMA), in the ranitidine drug and a distribution halt in Canada announced late Tuesday.
The move comes after the US Food and Drug Administration and European Medicines Agency announced earlier this month that tests showed some ranitidine products contained NDMA, which is classified as a probable human carcinogen based on lab tests. It also now includes information that Zantac maker Sanofi has no plans to stop distributing or making Zantac and its generic versions outside of Canada.
However, it did recommend that those buying ranitidine medicines over-the-counter could consider using other medicines approved for their conditions.
Several drugs are approved for the same or similar uses, the FDA noted.
Nokia 7.2 with 48MP camera, gradient colours official in India
The front camera sports a 20-megapixel Zeiss quad-pixel snapper with f/2.0 aperture for selfies and video calling. Flipkart customers will also be eligible for 5% cashback on buying the phone using HDFC Bank Debit Cards.
Superdome Pressure Washer 'Paints' Tribute To Brees On Surgery Day
The team has given no official timetable on Brees' return, but initial estimates suggested it could take roughly six weeks. Jared Goff and the Los Angeles Rams didn't waste the opportunity created by Brees' absence to beat the Saints again.
Antonio Brown Avoids Commenting on NFL Investigation Into Sexual Assault Allegations
It's nearly impossible to find a concrete place to begin with Brown although his helmet grievances are probably a good start. And as the NFL does its own investigation - the league met with Taylor for ten hours on Monday - Brown continues to play.
A distribution halt is not the same as a full recall, and it means that generic Zantac (ranitidine) remaining on store shelves can still be sold, CBS News reported.
Meanwhile, the French pharmaceutical company that makes Zantac, Sanofi, said in a statement Wednesday "there are now no plans to stop distributing or manufacturing Zantac or other ranitidine products outside of Canada".
NDMA is the same chemical that has been linked to dozens of recalls of prescription blood pressure drugs in the past year, including a commonly prescribed one called valsartan.
"Our internal investigation is ongoing to determine further details", a Novartis spokesman said.
Novartis said in an emailed statement its step was precautionary and adequate measures "will be implemented in alignment with relevant health authorities as required".
The authority added that it is working with the companies supplying these medicines and global regulatory agencies to verify the causes of the nitrosamine contamination, and to identify the necessary measures to address the issue.