The FDA posted a notice indicating that they continue “to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine and is now aware of NDMA in nizatidine, which is chemically similar to ranitidine.“ They have found levels on NDMA in one company’s product that exceed the accepted limits and that company has initiated recall of its products from the market. It is now believed that both closely related products are potentially susceptible to NDMA increases over the shelf life of the product and when the product is stored at higher than normal room temperature.
The investigation continues, and, as you may know, all of the ranitidine products have recently been temporarily removed from the market (see previous post here). The FDA is working with firms to define the problem and see if there is a fix that can be instituted. The article provides recent testing results that FDA conducted.
We will keep you updated as more information is released by the companies or the Agency.
