Kirk Hessels, a spokesman for Camber, didn't immediately respond to requests for comment on Friday. (RNN) – A recall traced to the widely-used blood pressure medication valsartan has expanded to two new products, produced by a previously affected drugmaker. Community Rules apply to all content you upload or otherwise submit to this site. / Blood Pressure Medication Recall List. In November, Mylan also recalled 15 heart attack and blood pressure medications and Sandoz recalled Losartan blood pressure meds. NDEA has been classified as a “probable human carcinogen” according to the International Agency for Research on Cancer. STOCK PHOTO/Getty Images. Prinston Pharmaceutical Inc., dba Solco Healthcare LLC. Late last month, Teva Pharmaceuticals pulled all lots of Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets for the same reason: too much NDEA in its Valsartan, the active ingredient made by Mylan India. Lawyers for plaintiffs, including 34 people and insurers that paid for contaminated drugs, filed a class-action complaint Monday claiming that Zhejiang Huahai's actions constitute "an explicit effort to conceal and destroy evidence and to willfully and recklessly introduce adulterated and/or misbranded" valsartan into the market. Alembic doesn't use DMF in its manufacturing process, according to spokesman Ajay Desai, who said the contamination likely occurred during analysis. American Health Packaging added to the list of recalls on March 7, 2019. That drug was first approved in the U.S. in 1996. The full list of expanded recalled batches can be viewed at https://www.fda.gov/Safety/Recalls/ucm627647.htm. The recall of Losartan is linked to a possible cancer-causing element known as NMBA. In July, five medications of Valsartan/Hyrdrochlorothiazide blood pressure drugs manufactured by Major Pharmaceuticals, Teva Pharmaceuticals and Solco Healthcare were recalled. You may have questions, we have answers. Diovan's DMF levels were among the lowest that tested positive. Representatives for Aurobindo and Lupin didn't respond to requests for comment. Mylan Pharmaceuticals Inc./Mylan Laboratories Limited. FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure April 19, 2019 / 1:31 PM / CBS News The FDA regulates those less stringently than the active ingredients that fight disease. Twitter Share. More blood pressure medications added to growing recall list The drugs are manufactured by Teva Pharmaceuticals. Making Sense of the Recent Blood Pressure Drug Recalls. According to the Food and Drug Administration, NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes. The three impurities are chemical compounds in the nitrosamines class and NDEA and NDMA are considered to be a probable cancer-causing risk in humans at certain exposure levels, and NDMA a potential one. Getty Images. American Health Packaging issued a voluntary recall March 7 of one lot of valsartan tablets in 160-mg dose prompted by manufacturer AurobindoPharma USA’s March 1 voluntary recall of additional lots of valsartan due to the detection of NDEA in the active pharmaceutical ingredient. Rx. According to the assessments that it has posted online, the FDA hasn't yet screened valsartan that Valisure tested from Aurobindo Pharma Ltd., Lupin Ltd. and Novartis. ** Most commonly prescribed blood pressure medications have an array of similar side effects. NMBA is a potential human carcinogen. 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. The FDA allows drugs to contain the equivalent of about 8.8 million nanograms of daily exposure to DMF. Which blood pressure medication that has the lowest side effects depends on how you react to specific medications and what side effects you find most bothersome. An expansion of the recall was announced March 19, 2019, on fda.gov: As of March 15, 2019, according to fda.gov: Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. Trending. Those suppliers provide components including inactive ingredients, of which Diovan has about eight. Teva Pharmaceuticals has issued a voluntary recall of its amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets, both used to treat high blood pressure, according to the FDA. The FDA announced the recall on its website Tuesday. The peripheral adrenergic inhibitors work in the brain to block signals that tell blood vessels to constrict. All rights reserved (About Us). An online pharmacy told U.S. regulators it found another cancer-causing chemical in widely prescribed blood-pressure pills, raising new questions about a complex global web of companies that produces medicine for millions of people. Some forms of valsartan may contain a cancer-causing agent, FDA says. Keep reading to find information about the earlier Teva recall and voluntary recalls by many other companies that make blood pressure medications. According to the FDA, Valsartan is used for the treatment of high blood pressure and for the treatment of heart failure, and to reduce cardiovascular mortality following myocardial infarction. As of March 1, 2019, AurobindoPharmaUSA expanded its voluntary recall. By Bloomberg . As blood-pressure drug recall widens, doctors say patients should pay attention, but warned against dropping a medication without professional guidance. … . Updated June 27, 2019, with new recall lots. In addition, it has updated the list of valsartan medicines not under recall as of March 19. As of March 19, 2019, the Legacy Pharmaceutical Packaging recall was expanded, affecting 40 lots. Select drug class. © 2021 Advance Local Media LLC. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer). The drugs, angiotensin II receptor blockers (ARBs), work by widening or … Valsartan is a decades-old treatment for hypertension that is frequently combined with other medicines into a single pill. See above for additional recalls by Torrent. In November, Mylan also recalled 15 heart attack and blood pressure medications and Sandoz recalled Losartan blood pressure meds. Some of the valsartan that was positive for DMF was on a list of medicines the FDA had earlier deemed safe to use amid the recalls, including drugs manufactured by Alembic Pharmaceuticals Ltd. and Macleods Pharmaceuticals Ltd., both based in India. Zhejiang Huahai has said it has been in close contact with the FDA since the recall began. A carcinogen is something that could cause you to have cancer. Carton NDC#: 60687-139-01 (CBS) Another pharmaceutical company is recalling blood pressure medication after detecting trace amounts of a cancer-causing chemical. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Advance Local. Only Generics. Valsartan has been in shortage since August, and the agency warned in its statement that "other types of products may fall into shortage soon," without offering any specifics. The lots similarly were found to contain N-methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the U.S. Food and Drug Administration … The FDA maintains a … Here are the 10 lots. A carcinogen is something that could cause you to have cancer. Yet another blood pressure medication manufacturer is announcing a massive recall of its products due to potentially cancer-causing impurities. To date, Legacy has not received any reports of adverse events related to this recall. DMF, as the solvent is known, is classified by the World Health Organization as a probable carcinogen. The FDA has added 80 lots of Amlodipine Valsartan blood pressure medication to the hypertension drug recall list that continues to grow. Even more recalls for blood pressure medications. Company Medicine NDC Lot Number Expiration; A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Valsartan 80mg Tablet: 54569-6582-1 : 342B17019: 09/2019: A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Valsartan 80mg Tablet: 54569-6582-1 : 342B17018: 08/2019: A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) … “Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited,” the Food and Drug Administration posted Tuesday. Latest blood pressure medication recall list, updated September 2019. » RELATED: Blood pressure medication recalls: Everything you should know, Atlanta doctors, experts say. Hundreds of lots of the medication have been recalled since last July. When drugs are made, the initial raw materials may need to change form before they go into a pill. Lower in the list are the Teva Pharmaceuticals lots under voluntary recall, as posted at fda.gov. Here's how to know what medications were impacted and who to contact. Blood pressure medication recall expanded again over potential cancer-causing ingredient. But the official limit considered "safe" for human consumption brings a much lower risk than the possible exposure from tainted drugs - causing less than one additional case of cancer in 100,000 people over a lifetime. The U.S. Food and Drug Administration has updated its lists of valsartan and losartan-containing blood pressure medicines under recall due to the … See also: sub-topics. / Blood Pressure Medication Recall List. It is rarely used due to its numerous side effects and drug interactions. © 2021 Advance Local Media LLC. Anne-Gerard Flynn | Special to The Republican. An FDA spokeswoman said the investigation continues and it is impossible to predict how many more recalls there might be. The company added five lots of the generic drug losartan (three lots of losartan potassium tablets and two lots of losartan potassium/hydrochlorothiazide tablets) to an April recall of more than 100 lots of the same medications. Note to readers: if you purchase something through one of our affiliate links we may earn a commission. Another blood pressure medication has been recalled over concerns it could contain trace amounts of carcinogens. 1 Wonder Woman 1984; 2 Susan Moore; 3 Rush Limbaugh; 4 Stephanie Mohr; 5 Emergency Food Supply; 6 Ron Burkle; 7 Private Jets Sale; 8 Dog Pet Insurance; 9 Playboi Carti; 10 Leslie West; Top Searches Holiday Gifts. Torrent Pharmaceuticals Limited recalled two lots of Losartan potassium tablets, USP because of trace amounts of N-nitrosodiethylamine (NDEA), which is a probable human carcinogen. An FDA statement Friday disclosed that the contaminants, called N-Nitrosodimethylamine and N-Nitrosodiethylamine, are created when "specific chemicals and reaction conditions are present . The drugs under voluntary recall block receptors in the body that contribute to conditions like high blood pressure. These batches were distributed domestically between March 2017 and November 2018. Valsartan in combination with Amlodipine or Hydrochlorothiazide is used for the treatment of high blood pressure. The agency said that the risk of a patient who took a recalled ARB getting cancer is low. A number of medications in the class of drugs known as angiotensin II receptor blockers have been under voluntary recall since July because of the detection of unacceptable levels of N-Nitrosodiethylamine (NDEA) and/or N-nitrosodimethylamine (NDMA) and, more recently, N-Nitroso N-Methyl 4-amino butyric acid (NMBA), in their active pharmaceutical ingredient such as losartan and valsartan as well as irbesartan. The impurity that may be … DMF is cheaper than some other solvents, making it appealing for companies coping with the bruising economics of the generic-drug business. Valsartan Tablets USP 160 mg, 100 count Unit Dose Blisters The recall covers two types of hypertension-treating tablets including Losartan potassium tablets and Losartan potassion / Hydrocholothiazide tablets. If you take valsartan for your high blood pressure, check the FDA lists. One consumer receiving a recent letter from his pharmacy on a recall of valsartan medication noted that he received a similar letter last year over “purity” issues. Latest blood pressure medication recall list, updated September 2019. Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. For people with high blood pressure, there’s a range of other approved medications available that may be safer and more effective than alpha-blockers and alpha-2 … Blood pressure medication recall expanded again over potential cancer-causing ingredient. Teva Pharmaceuticals has issued a voluntary recall … She said that drug manufacturers will continue to test their products and recall pills that contain impurities over an interim limit the FDA established to make sure patients can continue to have access to the medications in the short term. See list above for the lots recalled in December. » RELATED: Blood pressure medication recalls: Everything you should know, Atlanta doctors, experts say Another 35 lots of heart and blood pressure medication losartan have been recalled because of unsafe amounts of NMBA in the active ingredient. You may have recently heard that FDA has recalled several blood pressure medications. Here are the Teva lots under recall as of November 2018, according to fda.gov. Next 21 results. Getty Images. Medications for high blood pressure include: Diuretics; Beta-blockers; ACE inhibitors; Angiotensin-receptor blockers; Calcium channel blockers; Alpha-blockers. Top Searches Holiday Gifts. Community Rules apply to all content you upload or otherwise submit to this site. Drugs used to treat High Blood Pressure The following list of medications are in some way related to, or used in the treatment of this condition. Is your blood pressure medication on growing recall list? An Attorney who has filed 12 high blood pressure medication lawsuits so far, told judges at a conference in the U.S. District Court in New Jersey last month he expected there to be at least 2000 high blood pressure medication lawsuits filed within the next two years. Blood Pressure Medication Recalled FDA says active ingredient is linked to a known probable carcinogen. (Individual Dose NDC: 60687-139-11). The FDA has said it thinks the potential carcinogens, known as nitrosamine impurities, are a result of the manufacturing processes the companies used. The voluntary recall was expanded in December by Mylan to all unexpired lots. The Food and Drug Administration (FDA) is issuing a worldwide recall for a blood pressure and heart failure medication that contains an active ingredient linked to an impurity that is a known probable human carcinogen. 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