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FDA Requests Removal of All Ranitidine Products From Market

For CMOs, CNOs, pharmacy

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Last week, the Food and Drug Administration (FDA) requested that manufacturers immediately withdraw all prescription and over-the-counter ranitidine products from the market, due to a possible contaminant. Ranitidine products, commonly known by the brand name Zantac, will not be available for new or existing prescriptions or over-the-counter use in the United States. 

The request was made because the FDA has determined that the contaminant known as N-Nitrosodimethylamine in some ranitidine products increases over time and when stored at higher than room temperatures. This may result in consumer exposure to unacceptable levels of this impurity.