recalled by Sandoz Canada, Apotex Inc., Pro Doc Limitée, Sanis Health Inc., and Sivem Pharmaceuticals ULC. The European Medicines Agency started a European Union-wide review of ranitidine medicines at the request of the European Commission. In October 2019, the U.S. FDA observed that a third-party laboratory was using higher temperatures in its tests to detect nitrosamine impurities. The NDMA was generated by the added heat, but the higher temperatures are recommended for using a gas chromatography–mass spectrometry method to test for NDMA in valsartan and angiotensin II receptor blockers. The FDA stated that it recommends using a liquid chromatography-high resolution mass spectrometry (LC-HRMS) testing protocol to test samples of ranitidine. Its LC-HRMS testing method does not use elevated temperatures, and has shown the presence of much lower levels of NDMA in ranitidine medicines than were reported by the third-party laboratory. International regulators using similar LC-MS testing methods have also shown the presence of low levels of NDMA in ranitidine samples. The FDA provided additional guidance about using another LC-MS method based on a triple-quadrupole MS platform. In September 2019, Sandoz issued a "precautionary distribution stop" of all medicines containing ranitidine, followed a few days later by a recall of ranitidine hydrochloride capsules in the United States. The Italian Medicines Agency recalled all ranitidine that uses an active pharmaceutical ingredient from Saraca Laboratories. The Federal Union of German Associations of Pharmacists (Arzneimittelkommission der Deutschen Apotheker) published a list of recalled products, as did the Therapeutic Goods Administration in Australia. In November 2019, the FDA stated that its tests found levels of NDMA in ranitidine and nizatidine that are similar to those that one may typically ingest with common foods such as grilled or smoked meats. The FDA also stated that its simulated gastric fluid model tests and simulated intestinal fluid model tests indicated that NDMA is not formed when exposed to acid in the stomach with a normal diet. The FDA advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). At the same time, it indicated that some levels of NDMA found in medicines still exceeded the agency's acceptable levels. In December 2019, the FDA asked manufacturers of ranitidine and nizatidine products to expand their NDMA testing to include all lots of the medication before making them available to consumers. In April