Additional recalls of generic versions of Zantac (ranitidine) have been announced in an effort to continue removing drugs from circulation that may contain the cancer-causing chemical N-nitrosodimethylamine (NDMA). Appco Pharma and Denton Pharma, operating as Northwind Pharmaceuticals, have complied with the FDA's recommendations and recalled both 150 and 300-milligram ranitidine products.
The FDA ranitidine recall targets any drugs which contain more than 96 nanograms of NDMA per million nanograms of ranitidine. The latest FDA ranitidine recall has also been accompanied by an announcement made on the FDA’s page on Jan. 8, 2020.
In the announcement, the FDA shared the findings of California-based lab Emery Pharma that ranitidine appears to form NDMA when exposed to heat. Following this revelation, Emery filed a petition with the FDA to have ranitidine transported in temperature-controlled vehicles, warn consumers if a lot of ranitidine had been exposed to heat, or suspend ranitidine from sale.
Some pharmaceutical retailers like CVS and Walgreens have voluntarily suspended the sale of ranitidine products including Zantac. Mylan Pharmaceuticals has also issued a voluntary recall for its 150-milligram and 300-milligram Nizatidine Capsules following the discovery of "trace amounts" of NDMA in the medication.
The companies involved in the most recent recall state no awareness of adverse events tied to their products. Patients are advised to discard their unused medication and discuss alternative treatment options with their physicians.