The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API), manufactured by Hetero Labs Limited, which was used in the manufacturing of the six (6) bulk lots of these drug products. Source: FDA Current as of January 17, 2020. Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. 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 tablets were repackaged for further distribution by Golden State Medical Supply under its product label. This recall is due to unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing medication containing NDEA above the interim acceptable intake limits of 0.27 parts per million (ppm). The .gov means it’s official.Federal government websites often end in .gov or .mil. Remember, not all ARBs are being recalled, and not all lots of valsartan, irbesartan, and losartan are affected and being recalled. 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. Update [5/6/2019] FDA is alerting patients and health care professionals to a voluntary recall of 19 lots of losartan potassium tablets made by Vivimed Life Sciences Pvt Ltd in Alathur, Chennai, India and distributed by Heritage Pharmaceuticals Inc, East Brunswick, New Jersey, due to the detection of the impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Certain irbesartan products labeled as Westminster Pharmaceuticals Inc. and GSMS Inc. recalled. Die Zulassung für Fresenius Kabi USA, LLC ist ab dem 8. If the lot number is on the medication bottle, it is usually imprinted on the label and is normally found next to the expiration date. 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 A list of lots affected by the voluntary recall … The finished product lots that are included in this voluntary recall and listed below were sold by Teva in bulk containers. Notably, we would like to stress that the actual risk to patients is likely much lower than our estimates, which reflect a scientific assessment of the highest possible exposure. The warning letter is another result of the agency’s ongoing investigation. 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. The agency will use the interim limits to recommend manufacturers conduct a voluntary recall if laboratory testing confirms the presence of nitrosamine impurities in finished drug product. For full drug product information, please refer to the full prescribing information for Losartan Potassium tablets USP. FDA posted a list of losartan medications under recall. We are also working to improve how companies submit manufacturing changes to the agency with the goal of further improving our review of the more than 5,000 quality-related application change requests (supplements) each year. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. However, through our ongoing track and trace efforts for prescription drugs in the supply chain, we’re working on ways to improve industry’s ability to track, detect and remove potentially dangerous drugs from the supply chain more rapidly and efficiently. Lantech acts as a contract solvent recovery facility for valsartan active pharmaceutical ingredient (API) manufacturing operations. Beginning in Summer 2018, FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that don’t meet the agency’s safety standards. FDA reminds manufacturers that it is their responsibility to develop and use suitable methods to detect impurities, including when they make changes to their manufacturing processes. ScieGen’s irbesartan products are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc. (GSMS). NMBA is a potential human carcinogen. FDA continues to work with companies and international regulators to ensure products entering the U.S. market do not contain nitrosamine impurities. NDMA has been found to increase the occurrence of cancer in animal studies. Therefore, FDA recommends patients use valsartan-containing medicines made by other companies or consider other available treatment options for the patient’s medical condition. The warning letter is another result of the agency’s ongoing investigation. A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) June 11, 2019 -- Teva Pharmaceuticals USA, Inc. has expanded its voluntary consumer-level recall originally initiated on April 25, 2019 in the United States of losartan potassium tablets. Instructions for returning recalled products are provided in the recall letter. FDA and international regulators have identified N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and NMBA in ARBs. Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled under the Golden State Medical Supply label should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Specifically, the warning letter cites Lantech’s failure to control and monitor procedures to recover solvents to ensure that they meet appropriate standards before reuse. Additionally, Legacy expanded its recall to include one additional lot of losartan tablets made with API manufactured by Hetero Labs. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. If you are taking a valsartan product, be sure to check to back as the lists may change. [UPDATED 06/02/2011] FDA’s meta-analysis of 31 randomized controlled trials comparing ARBs to other treatment found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs. See the list of irbesartan products under recall. Torrent is recalling only those lots of losartan medication that tested positive for NDEA above the acceptable daily intake of 0.27 ppm. Feb-2020. Mylan voluntarily recalled valsartan-containing products on November 20. To put this in context, currently one out of every three people in the US will experience cancer in their lifetime. It also is important to know not all ARBs contain NDEA or NDMA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition. This recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the losartan … Mai 2020 wirksam., Senden Sie schriftliche Anfragen losartan vs lisinopril bewertungen für Einzelexemplare der EUAs an das Büro für Terrorismusbekämpfung und Neue Bedrohungen, Food and Drug Administration, 10903 New Hampshire Ave., Geb. Update [1/18/2019] FDA is alerting patients and health care professionals to a voluntary recall of one lot of irbesartan and seven lots of irbesartan and hydrochlorothiazide (HCTZ) combination tablets distributed by Solco Healthcare LLC, a Prinston Pharmaceutical Inc. subsidiary. RemedyRepack, a repackager of Torrent’s valsartan/amlodipine/hydrochlorothiazide (HCTZ) tablets, has also recalled. The agency wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA. The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets … Consumers with questions regarding this recall can contact your dispensing pharmacy during normal business hours. Losartan is available as a generic drug but is also sold under the brand name Cozaar. IMPORTANT: Medications containing only amlodipine or hydrochlorothiazide (HCTZ) are not being recalled. The products subject to recall are listed below and packaged in bottles. The agency also updated the list of valsartan products under recall and the list of valsartan products not under recall. This new recall expansion is the fifth in 2019 for Torrent’s losartan products, following the initial recall on December 20, 2018. 42(3): p. 321-338. Die chemische Bezeichnung von Losartan ist 2-Butyl-4-chlor-1-{4-[2-(2Htetrazol-5-yl)phenyl]benzyl}imidazol-5-methanol. Pharmacies and healthcare facilities that have the product being recalled from above listed lots should stop using and dispensing the product immediately. This will provide an additional option for regulators and industry to use to detect both impurities. In addition to updating the lists, FDA revised information related to A-S Medication on the list of products included in the recall. The agency reminds manufacturers they are responsible for developing and using suitable methods to detect impurities, including when they make changes to their manufacturing processes. 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 warning letter outlines several manufacturing violations at Torrent’s Taluka-Kadi, Indrad, Gujarat facility, including failure to follow written procedures for production and process control and failure to adequately investigate batch discrepancies. Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. Update [1/3/2019] Torrent Pharmaceuticals is expanding its voluntary recall to include eight additional lots of losartan potassium tablets, for a total of 10 lots. Losartan Recall Lawsuit Losartan is a popular blood pressure medication that has been voluntarily recalled multiple times due to the presence of a human carcinogen. With this recall, Teva has now recalled all their unexpired valsartan-containing products from the U.S. market. We are working to incorporate what we have learned about the process risks that caused these impurities into our oversight of drug manufacturing, which includes how we assess applications and changes to applications, as well as enhancing our inspection coverage to evaluate the controls in place to prevent unacceptable levels of nitrosamine. 0781-5701-31. Weinitially estimated that if 8,000 people took the highest valsartan dose (320 mg) containing N-Nitrosodimethylamine (NDMA) from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of those 8,000 people. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Audience: Cardiology, Oncology, Family Practice. Camber Pharmaceuticals, Inc. has recalled 87 lots of Losartan Tablets USP. 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. 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. Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA. 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). FDA reminds patients taking recalled ARBs to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. If you are taking any medication containing an ARB, compare the information on your prescription bottle with the recall list to determine if your current medicine has been recalled. Teva is recalling lots of losartan-containing medication that tested positive for NMBA above 9.82 parts per million. In fact, we issued guidance in early 2018 to provide information to manufacturers regarding their responsibilities to assess the risks and implement appropriate controls for their manufacturing process. To date, Camber has not received any reports of adverse events related to this recall. Some ARBs contain no NDMA or NDEA. 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. The following additional repackagers are recalling or are expected to recall valsartan-containing products. We have consistently and transparently communicated with pharmacists, patients and health care professionals about the ARB recalls as they have evolved. For additional information about ARB products, see: Update [10/24/2018] FDA continues to evaluate valsartan-containing products and other angiotensin II receptor blockers (ARBs), and has updated the list of products included in the recall to add one additional lot of RemedyRepack. To find out if your medication has been recalled, you need the following information: Following is an example of an ARB medication label to help you identify the information on your medication: Note the manufacturer may be different from the distributor or labeler of your medication. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. If a manufacturer detects new or higher levels of impurities, they should fully evaluate the impurities and take action to ensure the product is safe for patients. The impurity detected is N-Methylnitrosobutyric acid (NMBA). Manufacturers should contact FDA’s Drug Shortages Staff when their testing of losartan shows levels of NMBA that exceed the interim acceptable intake limit of 0.96 ppm. Update [1/23/2019] Torrent Pharmaceuticals is further expanding its voluntary recall to include six additional lots of losartan potassium and hydrochlorothiazide combination tablets, for a total of 16 lots of losartan-containing medicines. Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA. The affected lots are being recalled due to an unexpected impurity in the manufacturers’ active pharmaceutical ingredient (API). NDC 13668-118-90, losartan potassium/hydrochlorothiazide tablets, USP 100 mg/25 mg, 90 count, batch number 4P04D007, expires on 7/31/2020. 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 Valsartan Recall List. Camber, Avet, Teva, and Torrent were affected by the recall. These methods can be used for drug substances and products, and users should validate them as part of good manufacturing practices and where data are used to support a regulatory submission or required quality assessment of the API or drug product. Get current information about recalls of blood pressure medications, FDA's Assessment of Currently Marketed ARBs, An explanation of FDA's ongoing recall of Valsartan, Losartan, and IrbesartanTranscript. See the list of valsartan products under recall and the list of irbesartan products under recall. 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 agency will continue to provide information when it becomes available. LOSARTAN POTASSIUM and HYDROCHOLOROTHIAZIDE TABLETS, USP 100 mg/12.5 mg, 90 count bottles. 1 Some of the previous recalls were due to N-nitrosodiethylamine (NDEA) impurity. If you have medicine included in the recall, contact your pharmacist. This recall is due to unacceptable amounts of N-Methylnitrosobutyric acid (NMBA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited. FDA reminds patients taking any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. Patients taking Losartan Potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. The lots were manufactured by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage) . 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. The bulk tablet lots were repackaged into seven (7) finished product lots for further distribution by Golden State Medical Supply under its product label. 12/31/2020. Any general questions regarding the return of this product should be directed to Qualanex at 1-888-280-2040 (live calls received 8 am - 9:00 pm Eastern Time). Test results from Hetero Labs show the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang. A widespread recall of common blood pressure and heart failure medications has been expanded to include more drugs containing losartan due to … This expanded recall includes six (6) lots of bulk losartan potassium USP Tablets (two lots of 50 mg strength and four lots of 100 mg strength) due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. 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. Report any adverse reactions with ARB-containing products, to FDA’s MedWatch program to help the agency better understand the scope of the problem: An official website of the United States government, : Patients taking losartan potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. FDA is working with manufacturers to reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs). The agency 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. Update [9/28/2018] FDA placed Zhejiang Huahai Pharmaceuticals on import alert on September 28, 2018, to protect U.S. patients while the active pharmaceutical ingredient (API) manufacturer fully determines how impurities were introduced into its API and remediates its quality systems. The agency continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-Nitrosodimethylamine (NDMA) and is taking swift action when it identifies these impurities that are above acceptable daily intake levels. As we work to safeguard the quality of our medicines, the American public can expect that we will act quickly to address any issue as soon as we find out about it to prevent as much harm to patients as possible. Our list of affected products and products without impurities remains available to the public, and we will update it when we have new information to share. FDA’s action follows a recent inspection at ZHP’s facility. Recall Notice: Frito-Lay Variety Pack Classic Mix 54 Count Item #910362 and Frito-Lay Variety Pack Classic Mix 30 Count Item #188140 Prima Wawona Peaches - Item Number 89407,17895,45518,23193 If we detect a problem, we will take appropriate action. Die Summenformel … BACKGROUND: ARBs are used in patients with high blood pressure and other conditions. Failure to correct these violations may result in further action by the agency. The presence of these nitrosamine impurities in ARB medicines was unexpected. 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. The recall was issued due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Consumers with questions regarding this recall can contact Inmar at 1-877-538-8443, Monday – Friday, 9am – 5pm EST. FDA is working with manufacturers to reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs). 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. Losartan potassium is a … Date 06/2020. Losartan Potassium, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct, 90ct, 500ct, 1000ct bottles. A pharmaceutical company has expanded the recall of its blood pressure medications — the latest development in a long list of recalls that have been happening for the past 14 months. In reality, the vast majority of patients exposed to NDMA through ARBs received much smaller amounts of the impurity than this worst-case scenario, and, since not all ARBs are affected, it’s very likely that a patient taking an ARB for four years would not have always received one of the affected products. Losartan Recall Lawsuit Losartan is a popular blood pressure medication that has been voluntarily recalled multiple times due to the presence of a human carcinogen. Sandoz’s losartan drug products make up less than 1 percent of the total losartan drug products in the U.S. market. Aurobindo is only recalling lots of valsartan-containing medication where NDEA has been detected above the interim acceptable intake limit of 0.083 parts per million. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) found in the medicine. It is also used to lower the risk of stroke in certain people with heart disease. Update [9/20/2019] Torrent Pharmaceuticals is expanding its voluntary recall to include five additional lots of losartan potassium tablets (three lots of losartan potassium tablets and two lots of losartan potassium/hydrochlorothiazide (HCTZ) combination tablets). For more information on the previous recall initiated on April 25, 2019, click here. 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). Not all Torrent losartan-containing medications distributed in the U.S. are being recalled. Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, 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. We continue to work with our global regulatory partners and industry as members of the International Conference on Harmonization (ICH) to publish guidance on controlling impurities in drugs and managing changes (e.g., ICHQ3A, Q3C, Q3D, Q7, Q11, and M7). Valsartan is a medication commonly used to treat high blood pressure and heart failure. FDA will determine, on a case-by-case basis, whether lots containing NMBA greater than 0.96 ppm should be released for distribution. This recall is due to trace amounts of N-Nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. generic component of commonly prescribed drugs used to treat high blood pressure and heart failure 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. FDA continues to evaluate the safety of 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. PHC/37/2020 - Class 2 Medicines Recall Action within 48 Hours Pharmacy and Wholesaler Level Pharmaram Ltd Clexane 4,000 IU (40mg) /0.4ml Syringes PLPI 33652/0067 Pharmaram Ltd has informed us that a … Note – “GSMS FG” refers to Golden State Medical Supply Finished Goods. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. FDA also updated the list of valsartan products under recall and the list of valsartan products not under recall. 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