fda losartan recall list

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. 31(3): p. 279-288. If you are taking any medication containing valsartan, compare the information on your prescription bottle with. On April 18, Torrent announced an expanded recall to include 36 more lots of losartan potassium and 68 more lots of losartan–hydrochlorothiazide combination tablets. FDA Expands Recall Of Multiple Blood Pressure Medications September 24, 2019 at 12:28 pm Filed Under: Blood Pressure , Expansion , FDA , Medication , Recall , Torrent Pharmaceuticals Limited Next 17 results. 1 Some of the previous recalls were due to N-nitrosodiethylamine (NDEA) impurity. Camber Pharmaceuticals is recalling certain valsartan tablets because they contain the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API). These methods were validated with respect to valsartan drug substances and drug products, but the agency expects them to have comparable LODs and limits of quantitation (LOQ) for other angiotensin II receptor blockers (ARB). The Valsartan Recall List. VALSARTAN RECALL LIST - FDA. Trending. The FDA has again expanded its recall of a type of generic blood pressure drug called an angiotensin II receptor blocker or ARB. FDA has product recall information from three additional repackagers of valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc. – labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack – and the agency has added them to the recalled products list. FDA is also posting new testing methods which can help manufacturers and international regulators detect and identify multiple nitrosamine impurities. The agency has also contacted other manufacturers of valsartan API to determine if their manufacturing processes are at risk for the formation of NDMA, and is working with them to ensure NDMA is not present in future valsartan API. 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). NDMA has been found to increase the occurrence of cancer in animal studies. 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). Trending. Van Apotex betreft het losartan kalium 50 en 100 mg, en losartan kalium/Hydrochloorthiazide 50/12,5 en 100/25 mg tabletten. Continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option. Trending. If you are taking a valsartan product, be sure to check to back as the lists may change. Vivimed is recalling lots of losartan-containing medication that tested positive for NMBA above 9.82 parts per million. The agency also updated the list of valsartan medicines not under recall accordingly. Not all valsartan products contain NDMA, so pharmacists may be able to provide a refill of valsartan medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition. Torrent is only recalling lots of losartan-containing medication containing NDEA above the interim acceptable intake limits of 0.27 parts per million (ppm). FDA will provide updates as more information becomes available. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan), Update: 11/13/2019 - FDA warns Mylan for CGMP deviations, Update: 10/15/2019 - FDA warns Torrent for CGMP violations, Update: 9/20/2019 - Torrent expands its voluntary recall of losartan, recalled angiotensin II receptor blockers (ARBs), 8/28/2019: STATEMENT: Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications, 6/26/2019: UPDATE - Macleods Pharmaceuticals voluntarily recalls losartan containing NMBA, 6/12/2019: UPDATE - Teva expands its voluntary recall of losartan, 5/6/2019: UPDATE - FDA alerts patients and health care professionals to Vivimed’s recall of losartan medication due to NMBA, 5/2/2019: UPDATE - Laboratory analysis of valsartan products, laboratory test results showing NDEA levels in recalled valsartan products, 4/29/2019: UPDATE - FDA alerts patients and health care professionals to Teva’s recall and Legacy’s expanded recall of losartan medication due to NMBA, 4/19/2019: UPDATE - Torrent further expands its voluntary recall of losartan; FDA posts new nitrosamine testing methods, 4/4/2019: STATEMENT - Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue, 3/22/2019: UPDATE - FDA updates recalled valsartan-containing and losartan-containing medicine information, list of valsartan medicines not under recall, 3/20/2019: UPDATE - FDA not objecting to losartan with NMBA below 9.82 ppm remaining on the market, 3/1/2019: UPDATE - Torrent again expands its voluntary recall of losartan; Hetero also voluntarily recalls losartan, 3/1/2019: UPDATE - Aurobindo expands its voluntary recall of valsartan and amlodipine/valsartan, 3/1/2019: PRESS RELEASE - FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall, 2/25/2019: UPDATE - Losartan distributed by Macleods Pharmaceuticals voluntarily recalled, 1/25/2019: STATEMENT - Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues, 1/23/2019: UPDATE - Torrent further expands its voluntary recall of losartan, 1/18/2019: UPDATE - Irbesartan distributed by Solco Healthcare voluntarily recalled, 1/3/2019: UPDATE - Torrent expands its voluntary recall of losartan, 1/2/2019: UPDATE - FDA alerts patients and health care professionals to Aurobindo’s recall of valsartan medication due to NDEA, list of valsartan products not under recall, 12/20/2019: UPDATE - FDA alerts patients and health care professionals to Torrent’s recall of losartan medication due to NDEA, 12/19/2018: UPDATE - FDA presents interim limits of nitrosamines in currently marketed ARBs, 12/12/2018: UPDATE - FDA updates NDMA and NDEA detection methods, announces posting of ZHP warning letter, 12/11/2018: PRESS RELEASE - FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications, 12/6/2018: UPDATE - Mylan expands its voluntary recall of valsartan-containing products, 11/27/2018: UPDATE - FDA alerts patients and health care professionals to Teva’s recall of valsartan products due to NDEA, 11/21/2018: UPDATE - FDA alerts patients and health care professionals to Mylan’s recall of valsartan products due to NDEA, 11/9/2018: UPDATE - FDA alerts patients and health care professionals to Sandoz’s losartan potassium and hydrochlorothiazide recall of one lot due to NDEA, 10/30/2018: UPDATE - FDA alerts patients and health care professionals to ScieGen’s irbesartan recall due to NDEA, 10/24/2018: UPDATE - FDA updates recalled valsartan-containing product information, the list of products included in the recall, 10/16/2018: UPDATE - FDA releases additional NDMA/NDEA detection method, chromatography-tandem mass spectrometry (GC-MS/MS) method, 10/11/2018: UPDATE - FDA releases method for detection and quantification of both NDMA and NDEA, 10/5/2018: UPDATE - FDA posts laboratory analysis of NDMA levels in recalled valsartan products, 9/28/2018: UPDATE - FDA places Zhejiang Huahai Pharmaceuticals on import alert, 9/24/2018: UPDATE - FDA updates recall lists and releases method for the detection and quantification of NDMA in valsartan, 9/13/2018: PRESS RELEASE - FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products, 8/30/2018: STATEMENT - Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings, 8/24/2018: UPDATE - FDA updates recall lists, 8/22/2018: UPDATE - FDA updates recall lists and releases method for the detection and quantification of NDMA in valsartan, 8/20/2018: UPDATE - FDA updates recalled valsartan-containing product information and presents NDMA levels in some foods, 8/9/2018: UPDATE - FDA updates recalled valsartan-containing product information, 8/2/2018: UPDATE - FDA updates recalled valsartan-containing product information and reminds API manufacturers to evaluate processes for unsafe impurities, 7/27/2018: UPDATE - FDA updates recalled valsartan-containing product information. Additionally, FDA is releasing a gas chromatography-mass spectrometry (GC/MS) headspace method for manufacturers and regulators to detect and quantify NDMA in valsartan API and finished drug products. Officials with the FDA have identified 40 angiotensin II receptor blockers (ARBs) that do not contain any known nitrosamine impurities. 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). The FDA has a list of 40 ARB drugs that are not affected by the recall. 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 … FDA’s action follows a recent inspection at ZHP’s facility. Update [8/20/2018] FDA is alerting health care professionals and patients that Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of valsartan/amlodipine/hydrochlorothiazide (HCTZ) tablets. These methods should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission. Some ARBs contain no NDMA or NDEA. The agency also updated the list of losartan products under recall. FDA is working with manufacturers to reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs). The combined headspace method and the combined direct injection method can detect and quantify NDMA and NDEA simultaneously in ARB API and finished drug products. Untreated hypertension (high blood pressure) leads to an increase in the risk of heart attacks and stroke. FDA posted a list of losartan medications under recall. The FDA is alerting patients and health care professionals to a voluntary recall of 44 lots of losartan potassium tablets by Teva Pharmaceuticals USA and … FDA updates table of interim limits for nitrosamine impurities in ARBs, FDA-published testing methods to provide options for regulators and industry to detect NDMA and NDEA impurities, An official website of the United States government, : 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. Not all Mylan valsartan-containing products distributed in the U.S. are being recalled. Visit the fda has also recalled it becomes available compare the information on your prescription bottle with option! 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