Since then, Sandoz announced that it is voluntarily recalling its generic version of the heartburn medication in the U.S., which is available over-the-counter and as a prescription medicine. Those drugs were contaminated with cancer-causing impurities through manufacturing flaws at pharmaceutical ingredient plants in China and India. NDMA is classified by Health Canada as a probable carcinogen.
Some generic Zantac is being pulled from major chain pharmacies in the USA shortly after French officials recalled all versions of the popular stomach drug amid a global investigation into a carcinogen found in the pills. Canadian health officials required drugmakers last week to halt distribution of all versions of Zantac.
To respond more quickly and efficiently to drug accidents in the future, the ministry plans to form and operate a council where relevant ministries, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korean Medical Association, Korean Hospital Association, and Korean Pharmaceutical Association participate.
That substance in this case, NDMA (N-Nitrosodimethylamine), also has caused the recall of numerous heart and blood pressure medications since July 2018. Earlier this week, Novartis-owned Sandoz recalled 30-count, 50-count and 500-count bottles of prescription ranitidine capsules, and overseas, British drugmaker GlaxoSmithKline is recalling ranitidine products in India and Hong Kong (it does not sell versions of the drug in the US). As per industry sources, most of the world's supply of the ranitidine API comes from two Indian firms: Saraca Laboratories and SMS Lifesciences.More news: Dorian Upgraded to Category 3 Hurricane as it Approaches Florida
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Health authorities on Thursday banned the sale of 269 common stomach drugs containing the antihistamine ranitidine.
Several generic heartburn medications have been recalled by Health Canada due to the detection of an impurity in some ranitidine drugs.
The company predominantly sells Ranitidine tablets in the United States markets, and its front end sales globally for the product were ~US$ 9 million in H1FY20.