Below you will find recent Class I and II recall notices provided to Smith Drug Company by the manufacturing community. Zydus currently offers over 80 FDA-approved generic products across a wide variety of therapeutic categories in the US. 1 Some of the previous recalls were due to N-nitrosodiethylamine (NDEA) impurity. This news follows a long string of recalls that happened last year for valsartan for similar contamination reasons. 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. Torrent Pharmaceuticals Ltd. has expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide tablets. "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. The new health alert tonight the makers of the blood pressure drug bazaar ten expanding their voluntary recall. If lot number information is not posted or you have any other concerns, please contact your Smith Drug Company Customer Service Representative. 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). 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. 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. 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. On April 18, the FDA issued a voluntary national recall of Losartan Potassium tablets, USP and Losartan Potassium/Hydrochlorothiazide tablets, USP. NMBA is a "potential human carcinogen," the FDA says. Contributing: Ken Alltucker. 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. Why is high blood pressure a 'silent killer'? Losartan 100 mg is not a controlled substance under the … 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. Etomidate injection, USP is intended for administration only by the intravenous route (see CLINICAL PHARMACOLOGY). In addition to treating high blood pressure, losartan is prescribed to protect the kidneys from damage that can occur in … The FDA has said the contaminants likely resulted from a manufacturing change adopted by factories in China and India that make the drug ingredients. A full list of lot numbers and expiration dates can be found here . 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. 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. It was not that long ago that the agency was announcing massive recalls of popular “ sartan ” blood pressure medications such as irbesartan, … Hundreds of lots of the medication have been recalled since last July. 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. 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. 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 Recall expansions also were announced January 3, January 22, March 1, and April 18. One of the raw ingredients, losartan potassium, USP, made by Zhejiang Huahai Pharmaceutical Co. contains the contaminant N-nitrosodiethylamine (NDEA). Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team. There have been more than a … Tests found trace amounts of a potentially, A full list of recalled drugs is available on the US Food and Drug Administration. Losartan potassium and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. 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 Beginnings 2001 - 2006 2007 - 2012 2013 - 2018 The Beginnings 2001 - 2006 2007 - 2012 2013 - 2018 Pill with imprint Z18 is White, Capsule-shape and has been identified as Losartan Potassium 100 mg. However, FDA officials said the cancer risk for any person who took valsartan that had the carcinogen N-nitrosodimethylamine, or NDMA, is small. 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. This latest recall is related to the valsartan recall that has been expanded multiple times since July. The drugs, angiotensin II receptor blockers (ARBs), work by widening or relaxing blood vessels, thus lowering blood pressure. 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 … Last month, Torrent Pharmaceuticals Limited issued a voluntary recall of two lots of Losartan potassium tablets over similar concerns surrounding trace amounts of NDEA. 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). 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 recall affects 6 lots of losartan potassium – hydrochlorothiazide tablets distributed after October 8, 2018. Torrent Pharmaceuticals Ltd. has expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide tablets. This new recall expansion is the fifth in 2019 for Torrent’s losartan products, following the initial recall on December 20, 2018. 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The impurity is N … Losartan Potassium 100 mg Film Coated Tablet Bottle 90 Tablets Zydus Pharmaceuticals 68382013716 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. The drug firm is recalling the drug due to the "presence of foreign tablets/capsules", the USFDA said. 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. (CNN)If you take blood pressure medicine, you'll want to double-check your bottle. Hypertension. The manufacturing change may generate the contaminants "when specific chemicals and reaction conditions are present" and can result of reusing materials such as solvents. This is part of an ongoi n g issue with angiotensin II receptor blocker (ARB) medications. There is positive evidence of human fetal risk during pregnancy. The recalled losartan and potassium/hydrochlorothiazide combination tablets contained small amounts of N-nitrosodiethylamine, or NDEA, according … Losartan is used in the treatment of high blood pressure; diabetic kidney disease and belongs to the drug class angiotensin receptor blockers. © 2021 USA TODAY, a division of Gannett Satellite Information Network, LLC. Zydus has losartan tablets available. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market. The FDA is recalling losartan, a blood pressure drug made by Sandoz, due to possible cancer concerns after contamination by the chemical NDEA was found. 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 lots contained levels of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the acceptable daily intake levels determined by the FDA. Heartburn drugs:FDA finds probable carcinogen in Zantac and other heartburn drugs. To check to see if your medication has been affected. 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. Two weeks before the end of 2015, PharmaCompass compiled a list of all the non-compliances issued in 2015 by major global regulatory agencies. Both substances are known as probable cancer-causing agents. It is supplied by Zydus Pharmaceuticals. 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. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, … To learn more about our history, select one of the time frames below. November 2020 Class II Mesalamine Delayed-Release Tablets 00591224522 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. Sandy P says: October 10, 2019 at 2:48 pm 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. Some losartan products sold in the US have been recalled because small amounts of NMDA (N-nitrosodimethylamine) or NDEA (N-nitrosodiethylamine) were found. Losartan 100 mg: 31722-702-30, 31722-702-90, and 31722-702-10. Updated 2251 GMT (0651 HKT) April 19, 2019. The expanded recall includes an additional three lots of losartan potassium tablets USP and two lots of losartan potassium/hydrochlorothiazide tablets. However, not all ARBs have been affected, and patients should continue to use their medication, the FDA says. about this recall, Zydus Pharmaceuticals, 1-877-993-8779. Many patients take a much lower dose of valsartan, and therefore their risks are theoretically much lower. New generic:FDA approves new valsartan generic to counter shortages of the blood pressure drug. The FDA said it will continue to test all products containing valsartan and similar drugs for the presence of impurities. Follow USA TODAY's Ryan Miller on Twitter @RyanW_Miller. 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