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Zantac Recalled Because of NDMA

Zantac Recalled Because of NDMA

In a move that was unsurprising, the FDA announced this week that they requesting all Zantac or Ranitinde products be removed from the pharmacies, shelves, stores, and market.

The decision has been expected for months. Costco, for example, has not allowed Zantac to be sold for months. Zantac is an over-the-counter medication – OTC – medication that is used to treat Heartburn.

Why is Zantac Recalled?

An ongoing investigation has been looking at a contaminant known as N-Nitrosodimethylamine (NDMA) that has been added to most all dosing of Zantac. It is this contaminant that is being investigated.

The FDA has determined that the impurity in some ranitidine products increases over time. When stored at higher than room temperatures, it may result in exposure to unacceptable levels of impurity.

The results have caused a complete recall of Zantac products.  But NDMA is in most medications – in this case – with ranitidine – levels are too high.

Statement by the FDA

“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”

What is NDMA?

N-Nitrosodimethylamine (NDMA) is a chemical that has been linked to a possible carcinogen. This means that it has cancer potential and higher levels. It is really important to understand the low levels of NDMA is not harmful. It is when those levels become unacceptable that there is a greater risk.

A study, done back in 2019, showed that NDMA was found in ranitidine. Lower levels of NDMA is commonly ingested in the diet. It is found in waters and some foods. At these lower levels, there is minimal risk to the individuals, but at sustained and unacceptable levels – there is an increased risk of cancer in humans.  The study done in 2019 did not contain enough data and proof to stop Zantac. However, a warning was placed.

FDA conducted additional testing that showed that NDMA levels increase in ranitidine even under normal storage conditions. This prompted the latest recommendation.

If You Have Ranitidine – What Should You Do?

Other medications can treat Heartburn. It is recommended that you switch to another medication.

As for the pills themselves, it is recommended that you dispose of the medication properly. There are locations that allow you to properly dispose of medications. Putting the pills down the sink or toilet is not recommended.

Source:  FDA Requests Removal of All Ranitidine Products (Zantac) from the Market