EMA recalls valsartan because of cancer-causing residue

Zhejiang Huahai Pharmaceutical, a Chinese active ingredient manufacturer, voluntarily notified the European Medicines Agency (EMA) that it had identified N-nitrosodimethylamine (NDMA), a chemical that might lead to cancer, in its valsartan provided to the European market. Medicines containing valsartan made by Huahai are being recalled across Europe, while the EMA carries out a thorough review to determine the impact.

FDA questions AbbVie’s procedures for handling death complaints

During an inspection AbbVie’s manufacturing plant located in North Chicago, FDA inspectors found that AbbVie had received five complaints tied to deaths after taking Humira and Venclexta. While the drugmaker reported those, the FDA says they did not go back and compile historical data about death complaints tied to drugs coming from the same lots. It turns out those lots had been tied to another 8 to 11 complaints each, the FDA noted in a Form 483 seen by STAT.