Drugmaker Mylan Pharmaceuticals, Inc. has issued a voluntary recall for three lots of the antacid Nizatidine (Axid) after traces of N-Nitrosodimethylamine (NDMA) were discovered in the active ingredient. Although no adverse events have been reported, Mylan is notifying all distributors, retailers, and customers, and has been making arrangements for the return of the affected products.
This month, a fourth Indian drug company involved in the manufacture of valsartan and another angiotensin II receptor blockers (ARBs) received an FDA warning letter over NDEA and NDMA found in its products.
Aurobindo Pharma USA, Inc. has issued a voluntary recall of three of its sartan-based prescription medications after discovering trace amounts of a carcinogenic substance known as N-nitrosodiethylamine (NDEA). The recall, which the FDA announced on Dec. 31st, affects a total of 80 lots of Valsartan, Amlodipine Valsartan, and Valsartan HCTZ pills with expiration dates between May 2019 and March 2021.
For the second time in as many weeks, the Food and Drug Administration has notified physicians and patients that yet another sartan drug used to treat hypertension has been contaminated with a carcinogenic industrial chemical. The manufacturer of the drug has issued a voluntary recall for a single lot of the medication losartan (potassium hydrochlorothiazide), identified as JB8912.
Only a few months ago, government health authorities in Europe and the U.S. issued recalls for the blood pressure medication valsartan over concerns of the presence of a carcinogenic industrial chemical known as N-nitrosodimethylamine (NDMA).
Last month, the China-based Zhejiang Huahai Pharmaceutical Company informed the European Medicines Agency that one of their products used in the treatment of hypertension, known as valsartan, had been contaminated with a chemical known as N-nitrosodimethylamine (NDMA). This substance is a known carcinogen that is used by researchers to intentionally produce cancer in laboratory rats.