Medicamentos Relacionados: Hyzaar, Losartan/Hydrochlorothiazide, Losartan Potassium And Hydrochlorothiazide, Cozaar
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FDA recall update April 2019
Valsartan is used to treat high blood pressure and help prevent heart attacks and stroke. It is in the Angiotensin II receptor blocker (ARB) drug class.
The U.S. Food and Drug Administration (FDA), Health Canada, and the UK Medical Health Products Regulatory Administration have issued recalls and/or warnings on various versions of the drug valsartan, losartan, and Irbesartan. The problem originally relates to an impurity identified in the manufacturing process of the active pharmaceutical ingredient at one facility in China.
The U.S. FDA has announced they are assessing currently marketed ARB drugs for impurities. You can stay updated on the drugs the FDA has tested to be safe here: FDA Assessment for ARB Products
Mylan Pharmaceuticals has expanded its voluntary recall to include all lots of non-expired valsartan-containing products due to trace amounts of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient (API) manufactured by Mylan Laboratories Limited.
The European Medicines Agency has issued a ban in the EU on a version of valsartan manufactured by Mylan in India. The problem relates to an impurity identified in some batches of valsartan. The EMA has stated Companies that manufacture ARB drugs are being required to review their manufacturing processes so that they do not produce impurities. See updates here.
The Drugs Standard Control Organization (CDSCO) of India has not issued a safety warning on this product.
We advise patients to check with their providers and/or pharmacists to determine if their version of Valsartan was affected, and to discuss other treatment options, if necessary.
U.S. FDA Valsartan, Losartan, Irbesartan Recall
Mylan Valsartan Recall
Health Canada Valsartan Recall
UK MHRA Valsartan Recall
EMA Valsartan Press Release
There are currently no U.S. pharmacy prices listed for generic Cozaar (losartan) 50 mg. Patients and caregivers who are struggling to afford prescription medication are encouraged to:
Laws affecting the importation of medication for personal use are different from country to country. For instance, personal drug importation is expressly legal in Australia. In the United States, technically, it is illegal to import unapproved medication under most circumstances, whether through purchase over the Internet or while on a trip to a foreign country. U.S. government officials have stated that individuals who order non-controlled prescription drugs from foreign sources (up to a three-month supply) for their own use are not being pursued or prosecuted. The U.S FDA regulates the safety and efficacy of medications sold in U.S. pharmacies. Medications dispensed from outside the U.S. are regulated for safety and efficacy by pharmaceutical/pharmacy regulatory authorities in their respective countries. Read about Advanced Pharmaceutical Regulatory Systems.
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