Losartan Potassium 100 mg Film Coated Tablet Bottle 90 Tablets Zydus Pharmaceuticals 68382013716 Losartan is used in the treatment of high blood pressure; diabetic kidney disease and belongs to the drug class angiotensin receptor blockers. 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. Zydus has losartan tablets available. Losartan 100 mg: 31722-702-30, 31722-702-90, and 31722-702-10. 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. 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. 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. It was not that long ago that the agency was announcing massive recalls of popular “ sartan ” blood pressure medications such as irbesartan, … 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. Losartan 100 mg is not a controlled substance under the … There is positive evidence of human fetal risk during pregnancy. 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accurate and up-to-date information as possible, like any printed material, the information on this website may become out of date over time. Many patients take a much lower dose of valsartan, and therefore their risks are theoretically much lower. Pill with imprint Z18 is White, Capsule-shape and has been identified as Losartan Potassium 100 mg. 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 recall affects 6 lots of losartan potassium – hydrochlorothiazide tablets distributed after October 8, 2018. New generic:FDA approves new valsartan generic to counter shortages of the blood pressure drug. If lot number information is not posted or you have any other concerns, please contact your Smith Drug Company Customer Service Representative. Zydus currently offers over 80 FDA-approved generic products across a wide variety of therapeutic categories in the US. The recalled losartan and potassium/hydrochlorothiazide combination tablets contained small amounts of N-nitrosodiethylamine, or NDEA, according … In January, the agency admitted that some versions of the drug valsartan contained trace amounts of a carcinogen for four years before regulators detected the impurity last summer. 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. 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However, not all ARBs have been affected, and patients should continue to use their medication, the FDA says. Both substances are known as probable cancer-causing agents. 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. Two weeks before the end of 2015, PharmaCompass compiled a list of all the non-compliances issued in 2015 by major global regulatory agencies. 1 Some of the previous recalls were due to N-nitrosodiethylamine (NDEA) impurity. However, FDA officials said the cancer risk for any person who took valsartan that had the carcinogen N-nitrosodimethylamine, or NDMA, is small. Last month, Torrent Pharmaceuticals Limited issued a voluntary recall of two lots of Losartan potassium tablets over similar concerns surrounding trace amounts of NDEA. Tests found trace amounts of a potentially, A full list of recalled drugs is available on the US Food and Drug Administration. © 2021 USA TODAY, a division of Gannett Satellite Information Network, LLC. This recall was prompted due to Camber Pharmaceuticals, Inc. 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 FDA issued more drug recalls for blood pressure medication losartan, recalled due to carcinogenic (cancer-causing) trace impurities. More information about the recall is available on the FDA website. There have been more than a … 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. 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. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market. A full list of lot numbers and expiration dates can be found here . Below you will find recent Class I and II recall notices provided to Smith Drug Company by the manufacturing community. And similar drugs for the treatment of hypertension said the contaminants likely resulted from a change. 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