Update [5/2/2019] FDA posted laboratory test results showing NDEA levels in recalled valsartan products as well as an assessment of the cancer risk from NDEA in valsartan. Update [6/26/2019] FDA is alerting patients and health care professionals to Macleods Pharmaceuticals’ voluntary recall of two lots of losartan potassium tablets (50mg strength) and 30 lots of losartan potassium/hydrochlorothiazide (HCTZ) combination tablets (12 lots of 50mg/12.5mg strength, three lots of 100mg/12.5mg strength, and 15 lots of 100mg/25mg strength). FDA continues to evaluate valsartan-containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall are affected and being recalled. Millions of people benefit from the high-quality products that the FDA regulates, and the U.S. has the most robust drug supply in the world, with strict standards for safety, effectiveness and quality. ... lot number 179791 that expire on March 31, 2020. The investigation into valsartan-containing products is ongoing, and the following list may change. Distributing losartan containing NMBA up to 9.82 ppm, will help maintain adequate losartan supply while companies obtain approval for manufacturing processes that produce nitrosamine-free losartan for patients. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. 160 November 2020 Class II Metformin Hydrochloride - Extended-Release Tablets 04948362309 04948362301 04948362350 04948362310 … The agency also updated the valsartan products under recall. In July 2018, the FDA announced a voluntary recall of several drugs containing valsartan, used to treat high blood pressure and heart failure, because of contamination with an impurity, the potentially cancer-causing chemical N-nitrosodimethylamine, or NDMA. Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. The recalled products contain an impurity, N-nitrosodimethylamine (NDMA), in the API manufactured by Zhejiang Huahai Pharmaceuticals, Linhai, China. This recall is due to unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in the losartan active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The lots were sold exclusively to Golden State Medical Supply of Camarillo, California. Additionally, FDA reminds patients taking this medication or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. The meta-analysis included data from over 60,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs for which adverse events related to cancer were captured during the study. April 17, 2020 - Buckhead Meat and Seafood of Houston - Recall of Frozen Flounder Sysco is the global leader in selling, marketing and distributing food products to restaurants, healthcare and educational facilities, lodging establishments and other customers who prepare meals away from home. Failure to correct these violations may result in further action by the agency.

A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Check out what's clicking on Foxnews.comTorrent Pharmaceuticals Limited said its Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, are affected by the recall.The ingredient detected was identified as N-Methylnitrosobutyric acid (NMBA), a known animal and potential human carcinogen. Date 06/2020. The Sandoz Inc. recall involved 100 milligram/25 milligram Losartan tablets with the lot number JB8912 and expiration date of June 2020. This will provide an additional option for regulators and industry to use to detect both impurities. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Teva has recalled other valsartan-containing products in recent months due to the presence of N-Nitrosodimethylamine (NDMA). The agency also updated the list of recalled losartan medicines. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. The amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per international Agency for Research on Cancer (IARC) classification. As part of our efforts to be transparent regarding impurities in ARBs, we want to make sure patients have a full understanding of how these impurities may affect them. 2020 Election Business Markets ... said Thursday that Torrent Pharmaceuticals has added eight additional lots of losartan potassium tablets to its recall list. The affected lots are being recalled due to an unexpected impurity in the manufacturers’ active pharmaceutical ingredient (API). Distributors and retailers that have product being recalled should immediately stop distribution, quarantine all remaining product in their control, and return the recalled product per the instructions given to them by Golden State Medical Supply, Inc. To aid industry and regulatory agencies, FDA has developed and published methods to detect NDMA and NDEA impurities – the gas chromatography/mass spectrometry (GC/MS) headspace method, the combined GC/MS headspace method, and the combined GC/MS direct injection method. Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out. However, it’s also important to underscore that there are ARB medicines that remain on the market and have been determined not to contain any nitrosamine impurities. Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. We understand that this medicine is … The immediate risk of harm to a patient’s health is likely to be higher if the medicine is stopped abruptly without any alternative treatment. Update [4/19/2019] Torrent Pharmaceuticals Limited is further expanding its voluntary recall to include 104 additional lots of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets. Untreated heart failure increases the risk of hospitalization and death. Live calls are received Monday-Friday, 9:00AM-5:00PM Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at druginfo@tevapharm.com. Adverse reactions or other problems experienced with the use of these products should also be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax. A widespread recall of common blood pressure and heart failure medications has been expanded to include more drugs containing losartan due to … Torrent is only recalling lots of losartan-containing medication containing NDEA above the interim acceptable intake limits of 0.27 parts per million (ppm). If you have questions about this recall, Medichem S.A., 1-201- 420-1800 November 2020 Class II Metformin Hydrochloride Extended Release Tablets 04948362401 CGMP Deviations If you have questions about this recall, Medichem S.A., 631-753- 9090; ext. The recent Angiotensin II Receptor Blocker (ARB) recalls have deeply concerned patients, the medical community, the agency and international regulatory bodies. Losartan Potassium Tablet and Losartan Potassium / Hydrochlorothiazide Tablet Lots. If you have medication samples from these companies, quarantine the products, and do not provide them to patients. Not all Mylan valsartan-containing products distributed in the U.S. are being recalled. Product labels associated with the lots being recalled will be posted to the FDA website under Recalls and Alerts. Update [1/2/2019] FDA is alerting patients and health care professionals to Aurobindo Pharma USA’s voluntary recall of two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient. Report any unexpected side effects with ARB-containing medicines, to FDA’s MedWatch program to help the agency better understand the scope of the problem: Return it to your pharmacist when you get your new medication. Recalled valsartan products labeled as Camber may be repackaged by other companies. NDC 13668-118-90, losartan potassium/hydrochlorothiazide tablets, USP 100 mg/25 mg, 90 count, batch number 4P04D007, expires on 7/31/2020. Update [3/20/2019] To ensure patient access to losartan, FDA will not object to certain manufacturers temporarily distributing losartan containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable intake limit of 0.96 parts per million (ppm) and below 9.82 ppm until the impurity can be eliminated. Untreated hypertension (high blood pressure) leads to an increase in the risk of heart attacks and stroke. Diovan oral tablet, Novartis, 160 mg, bottle, 90 count, NDC 00078-0359-34; Diovan oral tablet, Novartis, 320 mg, bottle, 90 count, NDC 00078-0360-34 Patients taking valsartan from a recalled batch should continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. Patient safety and product quality are critical to Teva. If the pharmacist cannot provide this, contact your doctor to discuss other treatment options. This recall is being conducted with the knowledge of the U.S. Food and Drug administration. FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one additional case of cancer over the lifetimes of these 8,000 people. We will post the method when it is available. To date, Teva has not received any reports of adverse events related to the lots being recalled. LOSARTAN POTASSIUM and HYDROCHOLOROTHIAZIDE TABLETS, USP 100 mg/12.5 mg, 1000 count bottles. Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles. The identifying NDC #s associated with Heritage distributed product are as follows:Losartan Tablets 25 mg: 90- count: NDC 23155-644-09, Losartan Tablets 50 mg: 90- count: NDC 23155-645-09; 1000-count: NDC 23155-645-10, Losartan Tablets 100 mg: 90-count- NDC 23155-646-09   1000-count: NDC 23155-646-10. The agency also updated the list of losartan products under recall. It is important to know that not all valsartan products contained NDMA, so pharmacists may be able to provide a refill of valsartan medication from batches that that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications. Losartan Potassium tablets, USP 25 mg, are light-green, film-coated, teardrop-shaped biconvex tablet with “LK 25” on one side and ">" on the other side. Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: [06/02/2011 - Drug Safety Communication - FDA] It is estimated that over the course of a person’s lifetime, consuming this amount of NDMA would result in less than one additional case of cancer for every 100,000 people. Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. FDA reminds consumers to continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option. Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall to incorporate additional repackagers of Camber’s valsartan products and Torrent’s recall. Estimated Range of Daily NDMA Consumption for certain foods (Recommended daily food consumption rates based on Dietary Guidelines for Americans 2015-2020), In more ordinary terms, for example, one pound of bacon may contain 0.304-0.354 micrograms of NDMA. The recall list … Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten. 42(3): p. 321-338. Be certain to check samples to ensure affected products are not given to patients. Continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option. Instructions for returning recalled products are given in the recall letter. FDA also updated the list of valsartan products under recall and the list of valsartan products not under recall. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products. FDA has determined the recalled valsartan products pose an unnecessary risk to patients. Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. Update [7/27/2018] FDA is updating health care professionals and patients after discovering that several additional companies that repackage drug products are also recalling valsartan-containing products. Jun 2, 2011. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 2 Chemie. We will update this statement as we have more information. Update [11/21/2018] FDA is alerting patients and health care professionals to Mylan Pharmaceuticals’ voluntary recall of 15 lots of valsartan-containing products due to the presence of N-Nitrosodiethylamine (NDEA).