Follow USA TODAY's Ryan Miller on Twitter @RyanW_Miller. Zydus currently offers over 80 FDA-approved generic products across a wide variety of therapeutic categories in the US. Losartan 100 mg: 31722-702-30, 31722-702-90, and 31722-702-10. 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. Updated 2251 GMT (0651 HKT) April 19, 2019. A full list of lot numbers and expiration dates can be found here . 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. In November, the FDA announced a voluntary recall of losartan potassium/hydrochlorothiazide, 100 mg/25 mg tablets in 1,000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912, Exp. On April 18, the FDA issued a voluntary national recall of Losartan Potassium tablets, USP and Losartan Potassium/Hydrochlorothiazide tablets, USP. 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. Heartburn drugs:FDA finds probable carcinogen in Zantac and other heartburn drugs. 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. New generic:FDA approves new valsartan generic to counter shortages of the blood pressure drug. 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accurate and up-to-date information as possible, like any printed material, the information on this website may become out of date over time. 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. Hypertension. NMBA is a "potential human carcinogen," the FDA says. 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. Losartan potassium and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. © 2021 USA TODAY, a division of Gannett Satellite Information Network, LLC. Losartan is used in the treatment of high blood pressure; diabetic kidney disease and belongs to the drug class angiotensin receptor blockers. It is supplied by Zydus Pharmaceuticals. The recall affects 6 lots of losartan potassium – hydrochlorothiazide tablets distributed after October 8, 2018. Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team. However, not all ARBs have been affected, and patients should continue to use their medication, the FDA says. (CNN)If you take blood pressure medicine, you'll want to double-check your bottle. The Beginnings 2001 - 2006 2007 - 2012 2013 - 2018 The Beginnings 2001 - 2006 2007 - 2012 2013 - 2018 November 2020 Class II Lansoprazole Delayed-Release Orally Disintegrating Tablets 06838277277 Failed Dissolution Specifications If you have questions about this recall, Zydus Pharmaceuticals, 1-877-993-8779. about this recall, Zydus Pharmaceuticals, 1-877-993-8779. zydus losartan recall aldactone (Jan 03, 2021) Losartan potassium (a derivative of Losartan) is reported as an ingredient of Losartan Zydus in the following countries: France; Important ... climatestrikewr.ca Sandy P says: October 10, 2019 at 2:48 pm The drugs, angiotensin II receptor blockers (ARBs), work by widening or relaxing blood vessels, thus lowering blood pressure. One of the raw ingredients, losartan potassium, USP, made by Zhejiang Huahai Pharmaceutical Co. contains the contaminant N-nitrosodiethylamine (NDEA). Some losartan products sold in the US have been recalled because small amounts of NMDA (N-nitrosodimethylamine) or NDEA (N-nitrosodiethylamine) were found. However, FDA officials said the cancer risk for any person who took valsartan that had the carcinogen N-nitrosodimethylamine, or NDMA, is small. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications. The manufacturing change may generate the contaminants "when specific chemicals and reaction conditions are present" and can result of reusing materials such as solvents. In addition to treating high blood pressure, losartan is prescribed to protect the kidneys from damage that can occur in … Zydus NSE 3.62 % Pharmaceuticals USA Inc, a subsidiary of Zydus Cadila, is also recalling 7,668 bottles of Carvedilol Tablets, used to treat high blood pressure, in the American market. The recalled losartan and potassium/hydrochlorothiazide combination tablets contained small amounts of N-nitrosodiethylamine, or NDEA, according … The company hasn't had any reports of users getting sick, but the impurity level in these pills is above what the FDA considers an acceptable daily intake level. 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. There have been more than a … The FDA has said the contaminants likely resulted from a manufacturing change adopted by factories in China and India that make the drug ingredients. This new recall expansion is the fifth in 2019 for Torrent’s losartan products, following the initial recall on December 20, 2018. Why is high blood pressure a 'silent killer'? Last month, Torrent Pharmaceuticals Limited issued a voluntary recall of two lots of Losartan potassium tablets over similar concerns surrounding trace amounts of NDEA. Two weeks before the end of 2015, PharmaCompass compiled a list of all the non-compliances issued in 2015 by major global regulatory agencies. This news follows a long string of recalls that happened last year for valsartan for similar contamination reasons. Losartan Potassium 100 mg Film Coated Tablet Bottle 90 Tablets Zydus Pharmaceuticals 68382013716 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 … The FDA said it will continue to test all products containing valsartan and similar drugs for the presence of impurities. Contributing: Ken Alltucker. Hundreds of lots of the medication have been recalled since last July. 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. To learn more about our history, select one of the time frames below. Little did we know that, while the world was wrapping up for the holidays, the U.S. Food and Drug Administration (FDA) would be busy issuing warning letters to Sun Pharmaceuticals (Sun) and Cadila Healthcare Ltd (Cadila / Zydus Cadila). Torrent Pharmaceuticals Ltd. has expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide tablets. The drug firm is recalling the drug due to the "presence of foreign tablets/capsules", the USFDA said. If lot number information is not posted or you have any other concerns, please contact your Smith Drug Company Customer Service Representative. 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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.