23/09/2019 · Valsartan. There have been so many types of valsartan recalled this year that the FDA has created a website listing just for them. The latest is American Health Packaging's 160 mg valsartan tablets, lot number 179791 that expire on March 31, 2020. The pills come in 100-count blister packs with NDC number 60687-139-01. 06/08/2018 · LYNCHBURG, Va. WSET - A medical recall has been expanded again, to a global scale.Valsartan, a prescription medication commonly used to treat blood pressure issues and heart failure, is now under a worldwide recall.The FDA said the drug contains a cancer. The FDA estimated that about 3 million Americans take valsartan to control blood pressure or protect their hearts. The recent recall affects more than half of the United States supply of the drug, the FDA said in an Aug. 30, 2018 statement.
The recalls are now world-wide, and this is the sixth recall of the drug since July. “We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. 06/08/2018 · A common drug used to treat blood pressure problems is now under a massive, international recall after being said to contain a cancer causing chemical. The United States Food and Drug Administration FDA said valsartan contains a chemical that can cause cancer called N-nitrosodimethylamine NDMA. FDA announced voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. FDA said that the recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine NDMA, made by the manufacturer - Zhejiang Huahai Pharmaceutical Co. Ltd. The valsartan recall was voluntarily initiated by Prinston Pharmaceutical November 27, 2017. On January 8, 2018, the FDA designated the recall Class II. The classification suggests use of the affected tablets could cause temporary or reversible adverse effects with a remote probability of serious harm. This company has stopped distributing valsartan. The FDA is working with the affected manufacturers – Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals – to reduce or eliminate impure valsartan from future products. The voluntary recall also applies to Solco and Teva valsartan/hydrochlorothiazide HCTZ combination products.
Valsartan tablets may be used alone or in combination with other antihypertensive agents. 1.2 Heart Failure. Valsartan tablets are indicated for the treatment of heart failure NYHA class II to IV. In a controlled clinical trial, valsartan tablets significantly reduced hospitalizations for heart failure. Valsartan and hydrochlorothiazide tablet USP is the combination tablet of valsartan, an angiotensin II receptor blocker ARB and hydrochlorothiazide HCTZ, a diuretic. Valsartan and hydrochlorothiazide tablet USP is indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled with monotherapy 1. FDA has updated lists of valsartan products under recall and valsartan products not under recall. Additionally, FDA reminds patients taking this medication or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. 06/07/2018 · Patients with conditions such as high blood pressure and heart failure have been urged to check their medication as regulators recall packs of valsartan made by two companies. A Europe-wide alert has gone out after a change in manufacturing process at a Chinese factory was found to result in medicine containing a carcinogenic substance.
16/07/2018 · FDA recall of certain generic valsartan products adds to similar EU action on finding of impurities 16-07-2018 Print. More on this story. Article Voluntary recall of Sandoz ranitidine capsules following detection of impurity. 25-09-2019. 06/07/2018 · Hong Kong’s Department of Health on Friday recalled five prescription drugs that are used to treat heart disease because they have the potential to cause cancer. An estimated 30,000 people could be affected by the recall of the valsartan-containing drugs,.
06/08/2018 · The U.S. Food and Drug Administration FDA has expanded its voluntary recall of several medications used to treat high blood pressure and heart failure over concerns that an active ingredient in the drugs could be contaminated with a cancer-causing agent. The agency reported that traces of N. 02/01/2019 · The new year brings a new blood pressure medication recall. This time Aurobindo Pharma USA has recalled 80 lots of its Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP and Valsartan Tablets USP due to a trace amounts of an impurity that. 18/07/2018 · This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. Major Pharmaceuticals has issued a nationwide voluntary recall of all lots of Valsartan, which is. 01/01/2019 · Aurobindo Pharma USA is voluntarily recalling 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level, due to the detection of trace amounts N-nitrosodiethylamine NDEA. An unexpected impurity, NDEA is a substance that occurs. 09/07/2018 · Urgent valsartan recall Carcinogenic potential with certain lines. July 9th 2018 Tagged: MHRA alert. By Ailsa Colquhoun. All batches of the following lines of valsartan are being recalled urgently due to possible contamination with a potentially genotoxic and carcinogenic impurity.
Valsartan Images. What does Valsartan look like? Note: Multiple pictures are displayed for those medicines available in different strengths, marketed under different brand names and for medicines manufactured by different pharmaceutical companies. 07/08/2018 · A voluntary recall of a medication to commonly used to treat blood pressure problems has now been expanded worldwide. The U.S. Food and Drug Administration says valsartan could contain a cancer-causing chemical called N-nitrosodimethylamine NDMA. Patients are advised not to stop taking the recalled Valsartan medicine unless they have been told to do so by their doctor or pharmacist. Healthcare professionals should follow specific advice from national authorities concerning medicines in their country. Not all Valsartan medicines are included in the recall.
Some forms of valsartan may contain a cancer-causing agent, FDA says. Here's how to know what medications were impacted and who to contact. 11/09/2019 · The Valsartan Heart Failure Trial Val-HeFT was a multinational, double-blind study in which 5,010 patients with NYHA class II 62% to IV 2% heart failure and LVEF <40%, on baseline therapy chosen by their physicians, were randomized to placebo or valsartan titrated from 40 mg twice daily to the highest tolerated dose or 160 mg twice daily and followed for a mean of about 2 years.
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