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According to the "Korean Biomedical Review", after a series of recalls of "sartan" drugs with potential safety hazards recently, Sanofi, a well-known foreign company, is withdrawing three hypertension drugs in the Korean market, namely Aprovel (generic name: Ecuador).
▍ EDQM azide impurity is a new mutagenic substance.
In June 2021, the Canadian health authority announced that Sanofi-Aventis Canada has recalled 12 batches of irbesartan drugs (brand names Avalide and Avapro, involving different doses) due to azide impurities, because the test found that the overlap Nitrogen-based impurities exceed acceptable limits
▍ EDQM azide impurity is a new mutagenic substance.
On September 13, 2019, the FDA and EMA issued an announcement on the detection of NDMA in related ranitidine drugs.
In January 2020, the FDA website published three NDMA-related recall notices
The common diabetes drug metformin has also been involved in a series of recalls in the past two years
On May 28, 2020, the FDA announced that due to the risk of NDMA impurities, Apotex, the largest generic drug company in Canada, voluntarily recalled all batches of metformin hydrochloride sustained-release tablets
On September 23, 2020, India Sun Pharmaceuticals stated that the company will recall some batches of RiometER (metformin hydrochloride sustained-release oral suspension, 500mg/5ml)
