In September 2019, The USFDA has observed that, some ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. We are one of the manufacturer of Ranitidine HCl Active Pharmaceuticals Ingredient (API).
We understand that through the FDA news release, The US Food and Drug Administration (USFDA or the Agency) has requesting Ranitidine formulation manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step taken by FDA in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications. FDA also made a statement as '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'.