Carcinogen FDA OTC Pharma Recall Voluntary Zantac

Zantac and Other Antacids Recalled For Carcinogens

It was recently discovered that Zantac products might contain a carcinogen that goes by the name N-nitrodimethylamine (NDMA). This carcinogen includes a low level of nitrosamine which is known to cause cancer. 

Strangely enough, NDMA is a commonly known environmental contaminant. If consumed in large amounts, it can lead to health issues. This chemical can be found found in the water we drink, food we eat, dairy products, meat, and some vegetables.

Because of the presence of NDMA in Zantac, three major drug stores in the United States have decided to voluntary remove all Zantac and antacid products from their shelves. Until these drugs are cleared by the US Food and Drug Administration, CVS, Walgreens, and Rite Aid, will not sell any products that may have NDMA.

Zantac has not only been recalled in the United States, regulators are taking the precaution for products being sold outside of the US. Recently, the sale of the drug was suspended in South Korea immediately after the news broke out about this drug. Similarly, a ban was placed in Bangladesh, and Canada, too, to halt the sale of the drug.

An online pharmacy, Valisure concerned about the health of their patients, filed a citizen’s petition about this drug. This ended up stirring up the FDA about Zantac containing the carcinogen. A petition that led to the FDA to run tests to determine the amount of NDMA present.

FDA is an agency that falls under the US Department of Health and Human Services. In addition to some other responsibilities, their job is also to protect the health of its citizens by making sure that the drugs, vaccines, and all the other biological products in the market made specifically for human use are safe to be used.  

As a response to the petition filed by Valisure, a report was conducted by FDA, and as per the report, ‘NDMA’s amount in ranitidine, which goes by the brand name Zantac, barely exceeds the amount of it in common food items that we eat daily.’ This report also stated that NDMA might be produced in the drug during the manufacturing process.

What’s more, is that this isn’t the first time NDMA has been discovered in drugs. For over a year, drug regulating agencies have been issuing warnings to different companies regarding this matter. 

A warning was issued when N-Nitroso-N-methyl-4-aminobutyric acid was discovered in the manufacturing process of Losartan Potassium, a drug by Teva Pharmaceuticals. Another warning letter was issued to Teva, in November of last year when Amlodipine, because of another cancer-causing impurity found in one of its drugs.

Two warnings were issued to Hetero Labs Ltd a pharmaceutical based in India. ScieGen Pharmaceuticals from New York received a warning because of a carcinogen found in a drug that they marketed to consumers.

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