Millions of Americans rely on ranitidine, popularly known by its brand name Zantac, for treating their heartburn and other acid reflux symptoms. Yet the Food and Drug Administration has recently demanded that all ranitidine products be removed from the market immediately.
This recall follows an ongoing investigation into levels of an environmental contaminant found in ranitidine. The contaminant, N-Nitrosodimethylamine (NDMA), has been proven to increase in ranitidine products over time when stored above room temperature. This may result in consumer exposure to unacceptably high levels of NDMA. Additionally, NDMA is a probable human carcinogen, meaning that, at high levels, it could stimulate cancerous growth in the body.
Current Testing of NDMA Levels in Ranitidine
The Food and Drug Administration (FDA) has been testing the levels of NDMA in ranitidine since the summer of 2019 after an independent laboratory discovered high levels of the contaminant in these products. When the (FDA) conducted its own testing to ensure that the NDMA did not exceed acceptable levels, only low levels of the contaminant were found. The administration stated that these low levels were not expected to lead to an increase in the risk of cancer.
Yet over time, subsequent testing showed that NDMA levels in ranitidine increased slowly over time under normal storage conditions and significantly when stored at higher than normal temperatures. Therefore, the older the ranitidine product is, the greater the level of NDMA.
Recall of Ranitidine Products from Store Shelves
While the Food and Drug Administration continues to test NDMA levels, it is requesting all manufacturers of ranitidine immediately withdraw their products from the market. Additionally, the FDA is advising consumers to dispose of their ranitidine products and not purchase or take any more until the investigation is complete and it concludes that levels do not exceed acceptable limits.
The agency urges patients who previously took ranitidine products to take alternative medications that are approved and do not carry the same risks to NDMA exposure.
Contact an Experienced Defective Drugs Attorney About Zantac or Other Ranitidine Products
If you have any questions or concerns regarding how the ranitidine recall may impact you, do not hesitate to reach out to our offices. The attorneys at Domnick Cunningham & Whalen are experienced and knowledgeable in defective drug cases and are here to advise you through any legal processes, even against bigger corporations. Call to schedule your consultation with a Zantac lawyer today.
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