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Food and Drug Administration requests recall of Zantac and ranitidine

| Jan 26, 2021 | Zantac and ranitidine |

The U.S. Food and Drug Administration (FDA) asked manufacturers to pull over-the-counter and prescription drugs with ranitidine, including Zantac, ranitidine and metformin. This was due to an FDA investigation launched in 2019 that determined that contaminant levels increased with long-term usage if they stored the drug at higher than average temperatures. That contaminant could pose a health risk to users.

The researchers did not find harmful levels of the cancer-causing environmental contaminant NDMA in many tests, but they also did not know how or for how long the samples were stored. The FDA asked that quality needs to be assured before again going to market. The FDA also asked that all users stop taking this drug and safely dispose of any leftover capsules – this advice counters typical drug recalls where the users return unused supply to a drug take-back location. The reason given was the risk of COVID.

What is NDMA?

N-nitrosodimethylamine, called NDMA, is an odorless liquid chemical. NDMA was once used to make rocket fuel, but it is also a byproduct of some manufacturing and water chlorination processes. It also may be found in soil, water and air. It is classified as a human carcinogen, which means it likely causes cancer in humans.

What are the impact areas?

This isn’t the first time NDMA contamination was found in drugs – the FDA recalled the blood pressure medicine valsartan in 2018. Ranitidine, however, forms in the body and could cause stomach, liver and bladder cancer.

Did you use this drug?

There were lawsuits surrounding valsartan, and there are now class actions against Zantac and its generic equivalent in California, Connecticut, Florida, Massachusetts, New Jersey, and elsewhere. Those who used the drug and got cancer in the stomach, intestine, liver, esophagus, colon, or rectal area may wish to contact an attorney about class action settlement.

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