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. DMF, as the solvent is known, is classified by the World Health Organization as a probable carcinogen. 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. Here's how to know what medications were impacted and who to contact. The FDA said in a March 22 posting on its website that it has updated the list of valsartan medicines under recall to incorporate additional repackagers of Aurobindo’s valsartan-containing medicine. Here are the Teva lots under recall as of November 2018, according to fda.gov. April 19, 2019 / 1:31 PM / CBS News Select drug class. 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. American Health Packaging added to the list of recalls on March 7, 2019. The U.S. Food and Drug Administration has updated its lists of valsartan and losartan-containing blood pressure medicines under recall due to the … On April 24, 2019, Legacy expanded its recall. DMF is cheaper than some other solvents, making it appealing for companies coping with the bruising economics of the generic-drug business. On Jan. 3, 2019, Torrent Pharmaceuticals Limited expanded  its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, according to fda.gov. A recent letter one consumer received from his pharmacy alerting him to check to see if his medication containing valsartan was among the lots listed in the letter under recall for “purity issues.”. 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 FDA has said it thinks the potential carcinogens, known as nitrosamine impurities, are a result of the manufacturing processes the companies used. Next 21 results. Blood pressure medication recall expanded again over potential cancer-causing ingredient. Getty Images. Anne-Gerard Flynn | Special to The Republican. —Also: 51 lots of Valsartan tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths). Valsartan Tablets USP 160 mg, 100 count Unit Dose Blisters Updated Sep 30, 2019; Posted Sep 30, 2019 . By Bloomberg . See also: sub-topics. For a complete list of the recalled medication, click here. Prinston Pharmaceutical Inc., dba Solco Healthcare LLC. 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. More blood pressure drugs are being recalled after being found to contain trace amounts of a potentially cancer-causing ingredient, one of a slew of recalls of medications to treat hypertension. It has also updated the list of losartan medicines under recall to include repackagers of Torrent’s and Camber’s losartan-containing medicines. (Individual Dose NDC: 60687-139-11). See below for previous Torrent recalls of other blood pressure medications. . Another blood pressure medication has been recalled over concerns it could contain trace amounts of carcinogens. 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 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. The recall covers two types of hypertension-treating tablets including Losartan potassium tablets and Losartan potassion / Hydrocholothiazide tablets. OTC. 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. (RNN) – A recall traced to the widely-used blood pressure medication valsartan has expanded to two new products, produced by a previously affected drugmaker. More blood pressure medications added to growing recall list The drugs are manufactured by Teva Pharmaceuticals. The drugs under voluntary recall block receptors in the body that contribute to conditions like high blood pressure. The full list of expanded recalled batches can be viewed at https://www.fda.gov/Safety/Recalls/ucm627647.htm. Note to readers: if you purchase something through one of our affiliate links we may earn a commission. A widespread recall of common blood pressure and heart failure medications has been expanded to include more drugs containing losartan making the total for one week to four recalls. Twitter Share. Diovan's DMF levels were among the lowest that tested positive. 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. A representative for Macleods couldn't be reached for comment. Following that is earlier Mylan recalls. In addition, it has updated the list of valsartan medicines not under recall as of March 19. 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. When drugs are made, the initial raw materials may need to change form before they go into a pill. Valsartan in combination with Amlodipine or Hydrochlorothiazide is used for the treatment of high blood pressure. Blood Pressure Medication Recalled FDA says active ingredient is linked to a known probable carcinogen. Approval was granted to India-based Alkem Laboratories Limited. That drug was first approved in the U.S. in 1996. According to fda.gov, as of Feb. 22, 2019: Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited. These product labels provided by fda.gov are for the Mylan recalled lots. Rx. Some forms of valsartan may contain a cancer-causing agent, FDA says. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Advance Local. The government site also says the risks of going off the medication may be greater than the risk of taking it so patients should not stop but should contact their health care provider or pharmacist for guidance. Need exclusive stories only we can tell? Keep reading to find information about the earlier Teva recall and voluntary recalls by many other companies that make blood pressure medications. In the 1950s, reserpine was one of the few products on the market to treat hypertension. » RELATED: Blood pressure medication recalls: Everything you should know, Atlanta doctors, experts say 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) … The focus surrounding valsartan has been on the active ingredient, largely supplied to the companies under recall by Zhejiang Huahai Pharmaceutical Co. in China and Hetero Labs in India. On Jan. 18, 2019, Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets used to treat blood pressure. Facebook Share. The finished products are manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited. Lower in the list are the Teva Pharmaceuticals lots under voluntary recall, as posted at fda.gov. Patients have been advised in the ongoing recall alerts to continue taking their current recalled medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure The U.S. Food and Drug Administration is alerting patients and health care professionals to another recall of medications used to treat high blood pressure and heart failure due to the presence of a potential cancer-causing substance. For now, if you are taking blood pressure medications, or any medications for that matter, pay attention to FDA warnings and recall news. Medications for high blood pressure include: Diuretics; Beta-blockers; ACE inhibitors; Angiotensin-receptor blockers; Calcium channel blockers; Alpha-blockers. An FDA statement Friday disclosed that the contaminants, called N-Nitrosodimethylamine and N-Nitrosodiethylamine, are created when "specific chemicals and reaction conditions are present . A carcinogen is something that could cause you to have cancer. For every 8,000 people who took the highest dose of valsartan contaminated with NDMA, there would be one additional case of cancer, the FDA has estimated. If you take valsartan for your high blood pressure, check the FDA lists. FOLLOW ANNALISE KNUDSON ON FACEBOOK AND TWITTER . 4 questions and answers for consumers about FDA’s recent high blood pressure medication recall. The agency last revised its allowable solvent levels in 2017; the WHO classified DMF as a probable carcinogen in 2018. Twitter Share. The latest news is that Torrent Pharmaceuticals Limited is further expanding its recall of Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, … Alembic doesn't use DMF in its manufacturing process, according to spokesman Ajay Desai, who said the contamination likely occurred during analysis. There was a time when the high blood pressure medication list was very short indeed. Community Rules apply to all content you upload or otherwise submit to this site. (CBS) Another pharmaceutical company is recalling blood pressure medication after detecting trace amounts of a cancer-causing chemical. An FDA spokeswoman said the investigation continues and it is impossible to predict how many more recalls there might be. The recall of Losartan is linked to a possible cancer-causing element known as NMBA. Is your blood pressure medication on growing recall list? A carcinogen is something that could cause you to have cancer. Teva Pharmaceuticals has issued a voluntary recall … Getty Images. In November, Mylan also recalled 15 heart attack and blood pressure medications and Sandoz recalled Losartan blood pressure meds. See above for additional recalls by Torrent. Valsartan is a decades-old treatment for hypertension that is frequently combined with other medicines into a single pill. 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. Subscribe to MassLive.com. The agency said that the risk of a patient who took a recalled ARB getting cancer is low. The FDA also posted labels of the Teva lots affected. The voluntary recall was expanded in December by Mylan to all unexpired lots. The drugs, angiotensin II receptor blockers (ARBs), work by widening or … On Jan. 22, 2019, Torrent Pharmaceuticals Limited expanded  its voluntary recall to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP. 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 … "This is what made me look up the website given in the letter on the FDA recall," he said. The FDA maintains a … The FDA announced March 12 that it had prioritized approval of another generic version of Diovan, that is, valsartan, in recognition of the multiple recalls of ARB medicines over the detection of nitrosamine impurities above interim acceptable intake limits. The carcinogens are found in smoked and grilled meats. The U.S. Food and Drug Administration is alerting patients and health care professionals to another recall of medications used to treat high blood pressure and heart failure due to the presence of a potential cancer-causing substance. Updated June 27, 2019, with new recall lots. The FDA regulates those less stringently than the active ingredients that fight disease. 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. Valisure found DMF in valsartan made by five of the six drugmakers it tested, including Novartis, which makes the brand-name version called Diovan. More blood pressure drugs are being recalled after being found to contain trace amounts of a potentially cancer-causing ingredient, one of a slew of recalls of medications to treat hypertension. You may have questions, we have answers. Carton NDC#: 60687-139-01 Updated Sep 30, 2019; Posted Sep 30, 2019 . The recalls were over the presence of NMBA. A recall of common blood pressure medication losartan has been expanded for a fifth time after manufacturer Torrent Pharmaceuticals found a possibly carcinogenic impurity in … Off-label. (CBS) Another pharmaceutical company is recalling blood pressure medication after detecting trace amounts of a cancer-causing chemical. by Kent Allen, AARP, August 7, 2018 | Comments: 0. Dozens of forms of generic valsartan have been recalled since July 2018, when the carcinogenic chemical N-Nitrosodimethylamine, or NDMA, was detected in a version of the drug made by a Chinese company. See list above for the lots recalled in December. . As of March 1, 2019, AurobindoPharmaUSA expanded its voluntary recall. ** Most commonly prescribed blood pressure medications have an array of similar side effects. 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 risk of cancer. Problems with potential cancer-causing agents in blood-pressure medications first cropped up in July, when an ARB called valsartan was recalled by Chinese drugmaker Zhejiang Huahai Pharmaceutical Co. A Bloomberg investigation found that an FDA inspector had raised concerns at the factory that made the valsartan in May 2017. Zhejiang Huahai has said it has been in close contact with the FDA since the recall began. The peripheral adrenergic inhibitors work in the brain to block signals that tell blood vessels to constrict. … 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. He added that his letter referenced that "some bottles of valsartan were recalled because of purity issues" but did not mention them as carcinogenic. The impurity detected in the finished drug product is N-nitrosodiethylamine, which is has been classified as a probable human carcinogen. The agency is urging patients to continue taking their medications until a pharmacist or doctor provides another option because they need to balance the risks of out-of-control blood pressure against that of a tiny elevated risk of cancer. —The 104 additional lots include 26 lots of Amlodipine and Valsartan tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths). The FDA posted Mylan labels, also at fda.gov. Novartis doesn't use DMF in making Diovan and documents provided by suppliers it purchases ingredients from indicate that they don't, either, said spokesman Althoff. Making Sense of the Recent Blood Pressure Drug Recalls. Even more recalls for blood pressure medications. When American Health Packaging recalled one lot of valsartan pills on March 7, the Public Interest Research Group said it was the 75th recall of blood pressure medications since the … 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. Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. Here are the 10 lots. Only Generics. 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. 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 … 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.