FDA Warning to Zantac Manufacturer Causes it to Make a Voluntarily Recall


Zantac voluntarily recalled by its manufacturer because of U.S. FDA warnings it contains cancer-causing impurity.

Recently the FDA alerted the public to the existence of low levels of the carcinogen, N-nitrosodimethylamine, or NDMA, in heartburn drugs known as ranitidine medications (in a class of drugs called H2 blockers). Zantac was one of the over the counter heart burn medicines that was effected.

The news caused Walmart, CVS Pharmacy and Walgreens to stop sales of any drugs that were effected, now being tested for their potential risks. NDMA has also been found in high blood pressure medication valsartan, now under FDA scrutiny.

The FDA has not demanded a recall of Zantac, but Zantac's manufacturer is expanding their voluntary recalls. On Friday, Sanofi announced a recall of Zantac OTC in the U.S. and Canada. Teva Pharmaceutical and GlaxoSmithKline, among others, have also begun recalls for versions of the medicine.

"Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods,” the agency said in its September alert.

CVS has said that customers who've purchased the products can return them for a refund and that “CVS Pharmacy will continue to sell other over-the-counter H2 blockers, including Pepcid, Tagamet and their respective generic equivalents, famotidine and cimetidine."

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