Zantac/ranitidine drug recalls due to NDMA impurity

Zantac/ranitidine drug recalls due to NDMA impurity

Multiple drug manufacturers have issued voluntary drug recalls for several Zantac drug products and its generic, ranitidine. Ranitidine is a histamine-2 receptor antagonist used to treat heartburn and related conditions. Potentially impacted customers are being notified with a recommendation to stop taking the medication and to discuss alternative therapies with their provider.

The recalls are due to discovery of an impurity (N-nitrosodimethylamine [NDMA]) in the finished product. NDMA is classified as a probable human carcinogen that may be found in certain foods, drinking water, and industrial processes. To date, none of the manufacturers has received reports of adverse events related to this recall; the FDA’s tests of alternatives have not shown NDMA in:

Additional information about the recalls can be found on the FDA website.

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