FDA Requests Removal of All Ranitidine Products from the Mar
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The U.S. Food and Drug Administration announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.

FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products. Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA.

In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert or follow the agency’s recommended steps, which include ways to safely dispose of these medications at home.

Source: https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
Dr. S●●●●●i B●●●●●i and 28 others like this40 shares
Dr. U●●●s B●●●●●●●r
Dr. U●●●s B●●●●●●●r Internal Medicine
Ranitidin should be banned in India also
Apr 2, 2020Like
Dr. V●●●●●●j D●●●i
Dr. V●●●●●●j D●●●i Legal Medicine
In response to the remark of 1 of the doctors which states that ranitidine should be banned in India also, please note that ranitidine has been a wonderful drug so far; it is not banned in USA; the USA report only says that if ranitidine is from the old stock NDMA level in it rises and such old ranitidine should not be used for this reason. Please don' t misunderstand this fact as equivalent to banning of ranitidine.... Read more
Apr 3, 2020Like4
Dr. N●●●●a G●●●a
Dr. N●●●●a G●●●a Obstetrics and Gynaecology
Just mention the expiry date judiciously, cheaper drugs are removed by the companies bery strategically to increase the use of new drugs which are actually just a bit different. Rantac is not a PPI hence works very well as h2 recepter inhibitor group.
Apr 16, 2020Like