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After numerous recalls, U.S. PIRG Education Fund applauds FDA order to remove all generic Zantac from stores
WASHINGTON -- The U.S. Food and Drug Administration (FDA) issued a full recall Wednesday of all ranitidine, a heartburn medication known by the brand name Zantac. Since 2019, this drug has been voluntarily recalled on multiple occasions, after independent laboratory testing discovered unacceptable levels of NDMA, a probable human carcinogen.
New testing has since revealed that the levels of NDMA found in ranitidine drugs can increase while the medication is stored under normal conditions, and more drastically when stored in high temperature settings -- which can occur during distribution and consumer usage. This is the first time that the FDA has requested a full recall of the medication, and the agency has sent letters to all ranitidine manufacturers to halt the manufacture and distribution of these products.
Grace Brombach, U.S. PIRG Education Fund Consumer Watchdog associate, put out the following statement in response:
“Americans have been taking these over-the-counter and prescription medications with the assumption that they would relieve their heartburn. But the truth is, while sitting in their medicine cabinets or on store shelves, these medications can also develop levels of cancer-causing impurities that may harm their long term health.
“While we are grateful to the FDA for investigating and eventually requesting a full recall, it has been more than 23 months since the first evidence surfaced. In the meantime, tens of millions of Americans have bought and taken potentially contaminated drugs. If you’ve already purchased over-the-counter ranitidine, you should stop and dispose of it immediately and discuss alternatives with your health care provider.
“Today’s announcement also begs the question -- why hasn’t the FDA taken similar steps with blood pressure medication? In the last year, the FDA has negotiated 75 voluntary recalls for blood pressure medications with similar nitrosamine contamination, but they haven’t requested a full recall. The FDA must finish their investigation quickly, and ensure that all medications reaching consumers aren’t contaminated with cancer-causing impurities.”
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