Large Scale Guidance on NDMA Contamination for Zantac Recalls

NDMA Contamination

On September 1st, the Food and Drug Administration provided guidance for drug manufacturers on detection and prevention for NDMA contamination. By and large, Zantac and many other pharmaceutical manufacturers who experienced cancer-causing NDMA contamination claim there were no methods of prevention available. Zantac has undergone a number of nationwide recalls because of N -nitrosodimethylamine or NDMA.

The recalls are only one element, and Zantac is far from being the only product recall because of NMDA contamination. Virtually all Ranitidine products are now off the shelves, even if temporarily. Nitrosamines such as NDMA are present in our air, water, and food. Nitrosamines do pose the risk of cancer, but only when exposed to high amounts for long periods of time. Zantac is one of many Ranitidine products that have undergone a series of legal battles because of the cancer-causing component. Victims of Zantac claimed that they were not aware of the cancer possibility, and would not have taken the drug if they had known about this possible side effect. 

What the FDA accomplished early last month was the identification of specific conditions that cause contamination to medications. They cited that contamination occurs in how the vendor sourced their materials, inadequate purification, and a clear lack of quality control throughout the manufacturing process. 

Now that experts have had some time to review the FDA’s guidance and feedback on NDMA contamination, it’s clear that many of these manufacturers we’re in a position to control the level of NMDA contamination in their products. Where a few months ago Zantac was claiming that they had no idea about the contamination and had no way of stopping it, the FDA is saying that if they sourced materials appropriately, purified their formula adequately, and paid attention to quality control then this wouldn’t be an issue. The FDA also provided a guide sheet to daily limits or exposure to NDMA.

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