A widespread recall of common blood pressure and heart failure medications has been expanded to include more drugs containing losartan due to an "impurity" that may pose a cancer risk. The FDA issued more drug recalls for blood pressure medication losartan, recalled due to carcinogenic (cancer-causing) trace impurities. On 9/19/2019, Torrent Pharma, Inc., recalled Losartan Potassium (all strengths) and Losartan Potassium/Hydrochlorothiazide (all strengths) due to the presence of an impurity. Follow USA TODAY's Ryan Miller on Twitter @RyanW_Miller. Updated 2251 GMT (0651 HKT) April 19, 2019. under recall, the U.S. Food and Drug Administration, FDA finds probable carcinogen in Zantac and other heartburn drugs, trace amounts of a carcinogen for four years, FDA approves new valsartan generic to counter shortages of the blood pressure drug, Your California Privacy Rights/Privacy Policy. However, FDA officials said the cancer risk for any person who took valsartan that had the carcinogen N-nitrosodimethylamine, or NDMA, is small. Many patients take a much lower dose of valsartan, and therefore their risks are theoretically much lower. The recalled losartan and potassium/hydrochlorothiazide combination tablets contained small amounts of N-nitrosodiethylamine, or NDEA, according … While Zydus aims to provide as accurate and up-to-date information as possible, like any printed material, the information on this website may become out of date over time. The manufacturing change may generate the contaminants "when specific chemicals and reaction conditions are present" and can result of reusing materials such as solvents. The lots contained levels of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the acceptable daily intake levels determined by the FDA. Pill with imprint Z18 is White, Capsule-shape and has been identified as Losartan Potassium 100 mg. Additional information can be found at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium. This news follows a long string of recalls that happened last year for valsartan for similar contamination reasons. The drug firm is recalling the drug due to the "presence of foreign tablets/capsules", the USFDA said. November 2020 Class II Mesalamine Delayed-Release Tablets 00591224522 Last month, Torrent Pharmaceuticals Limited issued a voluntary recall of two lots of Losartan potassium tablets over similar concerns surrounding trace amounts of NDEA. © 2021 USA TODAY, a division of Gannett Satellite Information Network, LLC. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, … Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team. about this recall, Zydus Pharmaceuticals, 1-877-993-8779. There have been more than a … The dose for induction of anesthesia in adult patients and in pediatric patients above the age of ten (10) years will vary between 0.2 and 0.6 mg/kg of body weight, and it must be individualized in each case. Page 1 of 3 Recall- Anastrozole Tablets, USP, 1mg – May 2019 PRODUCT RECALL RESPONSE FORM URGENT DRUG RECALL- RETAIL LEVEL 05/03/2019 Please complete the required information and fax to 1-817-868-5362 or email to rxrecalls@inmar.com To the Attention of Drug Safety/ Recall Services-Zydus Pharmaceuticals USA Inc. It is supplied by Zydus Pharmaceuticals. One of the raw ingredients, losartan potassium, USP, made by Zhejiang Huahai Pharmaceutical Co. contains the contaminant N-nitrosodiethylamine (NDEA). 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 more batches of the drug, federal health officials said. Torrent Pharmaceuticals Ltd. has expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide tablets. If lot number information is not posted or you have any other concerns, please contact your Smith Drug Company Customer Service Representative. Why is high blood pressure a 'silent killer'? I am trying to find out if there has been a recall or issues reported with the generic drug Pivasta 2 which is manufactured by Zydus Cardiva. The recall comes amid a larger string of recalls of blood pressure medications valsartan, losartan and irbesartan that contain trace levels of carcinogens NMBA, N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), the FDA says. Losartan 100 mg: 31722-702-30, 31722-702-90, and 31722-702-10. Three additional lots of losartan potassium tablets and two additional lots of losartan potassium/hydrochlorothiazide tablets were under recall, the U.S. Food and Drug Administration said Thursday. This latest recall is related to the valsartan recall that has been expanded multiple times since July. In addition to treating high blood pressure, losartan is prescribed to protect the kidneys from damage that can occur in … The FDA put the Chinese company Zhejiang Huahai Pharmaceutical on an, The FDA started testing all heart drugs called, It's unclear exactly what the cancer risk is if you take the contaminated pills; the. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications. Losartan 100 mg is not a controlled substance under the … The new health alert tonight the makers of the blood pressure drug bazaar ten expanding their voluntary recall. It was not that long ago that the agency was announcing massive recalls of popular “ sartan ” blood pressure medications such as irbesartan, … The expanded recall includes an additional three lots of losartan potassium tablets USP and two lots of losartan potassium/hydrochlorothiazide tablets. NMBA is a "potential human carcinogen," the FDA says. It estimated that if 8,000 people took the highest dose of valsartan (320 milligrams) containing the impurity, N-nitrosodimethylamine or NDMA, from these recalled batches daily for four years, there may be one additional case of cancer over the total lifetimes. 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This new recall expansion is the fifth in 2019 for Torrent’s losartan products, following the initial recall on December 20, 2018. FDA scientists concluded there would be one more cancer case above average rates for every 8,000 people on the highest dose of valsartan for four years. There is positive evidence of human fetal risk during pregnancy. To learn more about our history, select one of the time frames below. "The risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment," federal health officials wrote in a statement. This is part of an ongoi n g issue with angiotensin II receptor blocker (ARB) medications. Some losartan products sold in the US have been recalled because small amounts of NMDA (N-nitrosodimethylamine) or NDEA (N-nitrosodiethylamine) were found. Etomidate injection, USP is intended for administration only by the intravenous route (see CLINICAL PHARMACOLOGY). 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