CHA News Article

FDA Requests Removal of All Ranitidine Products From Market
For CMOs, CNOs, pharmacy

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. 

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