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. “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. It is supplied by Macleods Pharmaceuticals Limited. Valsartan is a prescription medication that is commonly used to treat high blood pressure and heart failure. Patients with medical questions regarding this recall or to report an adverse event may contact Macleods at (855) 926-3384 (8:00 am – 5:00 pm (EST). Here’s the growing list. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. This news follows a long string of recalls that happened last year for valsartan for similar contamination reasons. FDA has issued a recall of certain lots of angiotensin II receptor blocker (ARB) high blood pressure medication containing valsartan, losartan, or irbesartan. More than a year before the notices went out, Motamed had tried to sound the alarm on what he flagged as potential systemic problems at two facilities in China and India that produce the active ingredients in generic valsartan and other blood pressure medications. Alembic was not the only company to hike valsartan prices during the recall. What does Valsartan look like? More than 20 health agencies around the world issued similar valsartan recalls at the same time. A common drug used to control blood pressure and help prevent heart failure is being recalled in 22 countries because it contains a chemical that poses a potential cancer risk. FDA does not endorse either the product or the company. Before sharing sensitive information, make sure you're on a federal government site. The reason for this is an impurity at the Chinese manufacturer Zhejiang Huahai Pharmaceutical. Though the impurity N-nitrosodiethylamine (NDEA) occurs naturally in many places, the International Agency for Research on Cancer classifies it as a “probable human carcinogen.” But even the FDA stated in January that the actual increased risk of cancer from taking Losartan, Valsartan or Irbesartan with too much NDEA is small. What medications are included in the current recall? The affected lots are being recalled due to an unexpected impurity in … January 24, 2019 - The UK's MHRA issued a further recall of three more batches of irbesartan, this time concerning 150mg and 300mg film-coated tablets supplied by Macleods … Cadista has valsartan tablets available. The FDA is investigating the issue Many of them are in recall status.--Valsartan products recalled and not recalled in Canada by Health Canada plus these updates from March 9, 2019 for Losartan in Canada. According to the company, Macleods Pharma USA is the U.S. division of Macleods Pharmaceuticals, LTD, based in Mumbai, India. Losartan medications are implicated in the same recall as some valsartan drugs. Major, Solco, and Teva discontinued valsartan tablets in July 2018. This includes some combination tablets which contain valsartan and amlodipine or valsartan, amlodipine, and hydrochlorothiazide. Class 2 Medicines Recall: Macleods Pharma UK Limited - Irbesartan 150mg Film-coated tablets, PL 34771/0079 (MDR 94-06/18) Macleods Pharma UK Limited is … Alembic, Aurobindo, Cadista, Macleods, and Novartis are not affected by this recall. Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. L13 (Valsartan 80 mg) Pill with imprint L13 is Red, Elliptical / Oval and has been identified as Valsartan 80 mg. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. The U.S. Food and Drug Administration said valsartan … The Medicines and Healthcare products Regulatory Agency’s (MHRA) announced on July 5, 2018 a valsartan recall in Europe. Patients who are on Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets, USP should continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. Its molecular formula is C 24 H 29 N 5 O 3, its molecular weight is 435.5, and its structural formula is: Valsartan USP is a white to practically white fine powder. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts. At present there is no evidence that this impurity has caused any harm to patients. The FDA flagged concerns about valsartan, which is used to treat high blood pressure and heart failure, on July 13. Losartan Potassium Tablets 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg, 100mg/25mg and 100mg/12.5mg  were distributed nationwide to Macleods wholesale distributor and retail customers. The non-profit group Institute for Clinical Evaluative Sciencessays emergency department visits jumped 55 per cent among those affected by a Health Canada recall of some valsartanproducts. Aurobindo, and Macleods refuse to provide updated availability information. Current Valsartan Lawsuits. The U.S. Food and Drug Administration recalled some medicine with the generic drug valsartan due to an impurity that could cause cancer. Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (12 lots  of  50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 100mg/25mg strength) to the patient level due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Valsartan is used in the treatment of high blood pressure; left ventricular dysfunction; heart failure; heart attack and belongs to the drug class angiotensin receptor blockers. Multidistrict litigation (MDL) related to valsartan products was formed in … ESPN baseball reporter, Miami native Pedro Gomez dies at 58: ‘A brutal shock’, Which Florida pharmacies have COVID vaccines available? L14 (Valsartan 160 mg) Pill with imprint L14 is Orange, Elliptical / Oval and has been identified as Valsartan 160 mg. https://www.miamiherald.com/news/health-care/article226749109.html Macleods on June 26 also recalled 32 lots of losartan potassium including two lots of 50 mg tablets and losartan potassium/hydrochlorothiazide tablets, including 12 lots of … There are many reasons why a drug may be recalled. See full prescribing information for VALSARTAN TABLETS. If you’ve recently filled Valsartan or Valsartan HCTZ with Humana Pharmacy, we wanted to let you know that certain manufacturers have issued a recall of select lots of the medicine. Health Canada announced a voluntary recall of six generic valsartan products in July 2018 due to nitrosodimethylamine, or NDMA. Consumers with medical questions regarding this recall or to report an adverse event can contact Macleods Pharmaceuticals Limited at 855-926-3384 (8:00 am - 5:00 pm EST). MacLeods Pharmaceuticals increased prices on four valsartan products … If you have any general questions regarding the return of this product, please contact Qualanex via email at recall@qualanex .com or call 888-280-2046 (7:00 am to 4:00 pm CST Monday to Friday). In July 2018, the FDA announced a voluntary recall of several drugs containing valsartan, used to treat high blood pressure and heart failure, because of contamination with an impurity, the potentially cancer-causing chemical N-nitrosodimethylamine, or NDMA. But in Florida at least, one mental health barometer actually improved — fewer people killed themselves in 2020 than in any time in recent years, newly released statistics show. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Valsartan is used in the treatment of high blood pressure; left ventricular dysfunction; heart failure; heart attack and belongs to the drug class angiotensin receptor blockers. Other drugs affected by the valsartan recall include losartan and irbesartan. Anyone with questions can contact Qualanex, which is handling the product returns for Macleods, via email at recall@qualanex.com or by phone at 888-280-2042, 8 a.m. to 5 p.m., Eastern time, Monday through Friday. Learn more about the recall and view the full list of recalled losartan. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products. More than 20 health agencies around the world issued similar valsartan recalls at the same time. The FDA prioritized the review of the drug’s application as a means to provide an additional supply of valsartan medication after the recalls. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. VALSARTAN - valsartan tablet, film coated Macleods Pharmaceuticals Limited-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. Macleods Pharmaceuticals Limited on Monday recalled one lot of the blood pressure medication losartan after discovering trace amounts of a probable carcinogen. The NDC Code 33342-064-10 is assigned to “Valsartan ” (also known as: “Valsartan”), a human prescription drug labeled by “Macleods Pharmaceuticals Limited”. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. In one year, 600 lots of valsartan were recalled due to carcinogens in the drug. It is supplied by Macleods Pharmaceuticals Limited. Thus, manufacturers may face an uphill battle defending themselves against these personal injury claims. Macleods Pharmaceuticals Limited on Monday recalled one lot of the blood pressure medication losartan after discovering trace amounts of a probable carcinogen. Since then, two other plants, including another in China and one in India, have been linked to the NDMA impurity or a similar contaminant called NDEA (N-nitrosodiethylamine). Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the … Initially, the FDA named just a handful of companies that were affected by this recall, but more companies were added over time. The FDA is working to make sure additional products are not contaminated and don’t become contaminated. Valsartan USP is chemically described as N-(1-oxopentyl)-N-[[2'-(1 H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. MacLeods Pharmaceuticals increased prices on four valsartan products … Here’s the latest from the FDA on blood pressure meds with a cancer-causing element, recall notice tells patients the same thing, Recall expanded again for heart, blood pressure and kidney drug over possible carcinogen, Another high blood pressure/heart medicine recalled for possible cancer-causing element, One pandemic positive: Suicides in Florida actually plummeted. Instructions for returning recalled products  are given in the recall letter. Macleods’ recall notice tells patients the same thing other companies’ notices have: Until you come up with an alternative treatment with your doctor or pharmacist, keep taking the Losartan. It is supplied by Macleods Pharmaceuticals Limited. Losartan tablets being recalled by Macleods were manufactured by Hetero Labs, a pharmaceutical company based in Hyderabad, India, which previously faced regulatory issues after NDEA was found in a batch of losartan in September 2018. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance … The coronavirus pandemic has clearly stressed out countless Americans. Real-time updates and all local stories you want right in the palm of your hand. Macleods is recalling 32 lots of generic losartan and losartan/HCTZ tablets due to the presence of NMBA, a potentially cancer-causing impurity. Macleods on June 26 also recalled 32 lots of losartan potassium including two lots of 50 mg tablets and losartan potassium/hydrochlorothiazide tablets, including 12 lots of … July 16, 2018 -- The FDA has announced a voluntary recall of several drugs that contain the heart drug valsartan because a possible carcinogen was found in … 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. Macleods is arranging for return of all recalled products to Qualanex. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out. Valsartan and hydrochlorothiazide tablet USP is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT 1 receptor subtype, and hydrochlorothiazide, a diuretic.. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2'-(1 H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-Valine. L13 (Valsartan 80 mg) Pill with imprint L13 is Red, Elliptical / Oval and has been identified as Valsartan 80 mg. Alembic was not the only company to hike valsartan prices during the recall. Multiple recalls have been associated with valsartan and many of these medicines are the focus of a global investigation by the FDA because of probable carcinogenic contamination. Valsartan and hydrochlorothiazide tablet USP is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT 1 receptor subtype, and hydrochlorothiazide, a diuretic.. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2'-(1 H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-Valine. low blood pressure; Dizziness; headache To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall. Safety Alerts, Losartan Potassium USP tablets and Losartan Potassium/Hydrochlorothiazide combination tablets, An official website of the United States government, : Multi ingredient medications may also be listed when applicable. The drug was manufactured in India. Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 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 of an unexpected impurity found in the finished drug product. Aurobindo, and Macleods refuse to provide updated availability information. In late June, Macleods Pharmaceuticals Limited announced a new recall because of trace amounts of NMBA, N-Nitroso-N-methyl-4-aminobutyric acid, which carries a … Sign up for the Afternoon Update and get the day’s biggest stories in your inbox. The first recall was in July 2018 when China's Zhejiang Huahai Pharmaceuticals recalled batches of valsartan for trace amounts of NDMA. He’s now charged with death, ‘Florida is going to kill us all.’ Watch fans pack the streets to celebrate Super Bowl. , director of the FDA’s Center for Drug Evaluation and Research. Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. The product was distributed as unit dose blisters with 100 tablets per carton. Macleods Pharmaceuticals Limited is notifying its distributors and customers by phone and/or in writing to immediately discontinue distribution of the specific lot being recalled and to notify their sub-accounts. Return to Pill Identifier… Other drugs affected by the valsartan recall include losartan and irbesartan. Why was Valsartan recalled? Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. There is positive evidence of human fetal risk during pregnancy. 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