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20 Jan 2021

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartandue to the presence of an impurity, N-nitrosodiethylamine (NDEA). AFX News. Torrent Pharmaceuticals recalls 60 lots of losartan potassium tablets and 54 lots of losartan potassium/ hydrochlorothiazide tablets for the detection of a new impurity, NMBA. Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. FDA expands recall on blood pressure drug 02:42 Last year was a particularly difficult time for Aurobindo when it came to the FDA. Torrent further expands its voluntary recall of losartan. Losartan Potassium Tablets 100 mg – 1000/Bottle View Details: ... Aurobindo adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Company Announcement. Aurolife Pharma, Indian-based Aurobindo’s US subsidiary, issued the recall after it was discovered that a number of products had been labelled with the wrong lot number, as well as potentially bearing the incorrect expiry date. Other drugs affected by the valsartan recall include losartan and irbesartan. NDMA has also been found in Zantac (ranitidine) heartburn medication. However, patients should consult with their pharmacist or physician who can advise them on alternative treatments. Other recalls from Mylan Pharmaceuticals, Aurobindo Pharma USA, Inc., and Torrent Pharmaceuticals Limited followed. To date, the company says it has not received any reports of patients suffering adverse effects related to the recall. Beginning in mid-2018, FDA found that several angiotensin II receptor blocker (ARB) medicines contained nitrosamine impurities and have been recalled because they do not meet FDA's safety standards. Aurobindo Pharma USA Inc has announced a voluntary recall over 80 lots of its valsartan tablets that are suspected to contain a chemical that has been classified as a possible human carcinogen. All three of the notifications were as a result of quality control issues at its Indian plants, with products produced at the relevant facilities destined for the US market. The recall totals 2,352 bottles of simvastatin tablets, … Click here for an updated list of Losartan products under recall. The recall was issued due to one lot of Metformin being tested and showed results for NDMA levels in excess of the Acceptable Daily Intake Limit. Manufacturers and exporters of bulk drugs, formulations, and oral suspensions. Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This time, the recall affects 5 lots: 3 lots of losartan potassium tablets and 2 lots of losartan/hydrochlorothiazide tablets. Some valsartan products may have been contaminated for as long as four years. In June 2019, it was revealed that parent company, Aurobindo, had received its third Form 483 of the year ​. Teva has losartan and hydrochlorothiazide 100 mg/12.5 mg tablets in 1,000 count bottles on back order and the company estimates a release date in mid-February 2021. The impurity involves a chemical called N-nitrosodiethylamine (NDEA), which the FDA describes as a "substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen.". Torrent further expands its voluntary recall of losartan. The Sandoz Inc. recall involved 100 milligram/25 milligram Losartan tablets with the lot number JB8912 and expiration date of June 2020. January 2, 2019 / 1:54 PM / CBS News Another pharmaceutical company is recalling blood pressure medication after detecting trace amounts of a cancer-causing chemical. The Valsartan Recall List. Lupin and Sandoz did not provide a reason for the shortage. 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. Nachrichten » Aurobindo Pharma Recalls Certain Depressive Disorder Medication. voluntary recall of two lots of losartan potassium 100 mg tablets due to N-Nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. 02.01.2020 | 13:49. Update ... 11/30/2020: 13668-118-90: Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. Rising discontinued all losartan and hydrochlorothiazide presentations. All forms of Zantac have been recalled as of April 2020. Products Affected - Description. Push Mitteilungen FN als Startseite. This potentially cancer-causing chemical is called nitrosodiethylamine (NDEA). Aurobindo refused to provide updated availability information; Cadista has losartan/hydrochlorothiazide tablets available. Artikel bewerten: (1) Aurobindo … Now, almost a year later, manufacturer Torrent Pharmaceuticals expands its voluntary recall for the 5th time. Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 12.5 mg, bottle, 30 count, NDC 62332-0049-30, Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 12.5 mg, bottle, 90 count, NDC 62332-0049-90, Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 62332-0049-91, Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 25 mg, bottle, 30 count, NDC 62332-0050-30, Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 25 mg, bottle, 90 count, NDC 62332-0050-90, Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 25 mg, bottle, 1000 count, NDC 62332-0050-91, Losartan and Hydrochlorothiazide oral tablet, Alembic, 50 mg/ 12.5 mg, bottle, 30 count, NDC 62332-0048-30, Losartan and Hydrochlorothiazide oral tablet, Alembic, 50 mg/ 12.5 mg, bottle, 90 count, NDC 62332-0048-90, Losartan and Hydrochlorothiazide oral tablet, Alembic, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 62332-0048-91, Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 12.5 mg, bottle, 30 count, NDC 68180-0216-06, Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 12.5 mg, bottle, 90 count, NDC 68180-0216-09, Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 25 mg, bottle, 30 count, NDC 68180-0217-06, Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 25 mg, bottle, 90 count, NDC 68180-0217-09, Losartan and Hydrochlorothiazide oral tablet, Lupin, 50 mg/ 12.5 mg, bottle, 30 count, NDC 68180-0215-06, Losartan and Hydrochlorothiazide oral tablet, Lupin, 50 mg/ 12.5 mg, bottle, 90 count, NDC 68180-0215-09, Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 100 mg/ 12.5 mg, bottle, 90 count, NDC 57237-0208-90 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 57237-0208-99 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 100 mg/ 25 mg, bottle, 1000 count, NDC 57237-0209-99 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 50 mg/ 12.5 mg, bottle, 90 count, NDC 57237-0207-90 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 57237-0207-99 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 30 count, NDC 00781-5204-31 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00781-5207-92 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00781-5204-92 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 00781-5204-10 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 25 mg, bottle, 30 count, NDC 00781-5207-31 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 25 mg, bottle, 1000 count, NDC 00781-5207-10 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Sandoz, 50 mg/ 12.5 mg, bottle, 30 count, NDC 00781-5206-31 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Sandoz, 50 mg/ 12.5 mg, bottle, 90 count, NDC 00781-5206-92 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Sandoz, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 00781-5206-10 - discontinued, Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00093-7369-98, Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 00093-7369-10, Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 30 count, NDC 00093-7368-56, Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 90 count, NDC 00093-7368-98, Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 1000 count, NDC 00093-7368-10, Losartan and Hydrochlorothiazide oral tablet, Teva, 50 mg/ 12.5 mg, bottle, 90 count, NDC 00093-7367-98, Losartan and Hydrochlorothiazide oral tablet, Teva, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 00093-7367-10. 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. A full list of the recalled products is posted on the FDA's website. Updated December 31, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. 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Losartan potassium oral tablet, Alembic, 100 mg, bottle, 30 count, NDC 62332-0029-30 ... and Torrent were affected by the recall. Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 03/2020: Aurobindo Pharma USA, Inc. Valsartan 40mg Tablet: 65862-570-30: 470180008A: 02/2020: ... For more information about the losartan recall and affected products, ... Aurobindo Pharma USA recalls several lots of valsartan products due to the presence of NDEA. Lupin did not provide a reason for the shortage. In December 2018, Torrent Pharmaceuticals began a voluntary recall of losartan due to the presence of small traces of … Three additional lots of losartan potassium tablets and two additional lots of losartan potassium/hydrochlorothiazide tablets were under recall, the U.S. Food … 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. / CBS News. 300 Leser. ... FDA alerts patients and health care professionals to Aurobindo’s recall of valsartan medication due to NDEA. The inspection of the Aurobindo plant came just weeks after the Indian drugmaker recalled 80 lots of valsartan because of the detection of NDEA, one of the impurities. Torrent Pharmaceuticals Limited has expanded its voluntary recall of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, … © 2019 CBS Interactive Inc. All Rights Reserved. Expiration dates range from May 2019 to March 2021. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT. The recall was expanded on June 11, 2019 to include six additional lots of bulk losartan potassium tablets, particularly two lots of 50 mg and four lots of 100 mg. January 2, 2019 / 1:54 PM Any application of this information for any purpose shall be limited to personal, non-commercial use. Aurobindo Pharma stopped from supplying irbesartan to the EU Low levels of NDEA have now also been found in a third sartan, irbesartan, made by another Indian company, Aurobindo Pharma. AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 39 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity. Rising discontinued losartan in August 2019. Aurobindo refuses to provide updated availability information. Cadista has temporarily discontinued losartan tablets due to issues with obtaining active ingredient. This recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the losartan … Torrent has losartan and hydrochlorothiazide tablets available in all presentations (from lots unaffected by the recall). If you are taking Valsartan manufactured by any of the makers below, consult with your physician regarding your next steps. Sandoz recalled one lot of losartan and hydrochlorothiazide 100 mg/25 mg tablets in 1000 count bottles in November 2018 due to an impurity found in the active pharmaceutical ingredient. Subscribe to AHFS Clinical Drug Information to get direct access to integrated drug shortages content, plus comprehensive and actionable drug information. The Food and Drug Administration announced Aurobindo Pharma USA, Inc. is voluntarily recalling 80 lots of Amlodipine Valsartan Tablets, Valsartan HCTZ Tablets, and Valsartan Tablets. A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) The recall covers 25 mg, 50 mg and 100 mg dosages. Merck has Hyzaar available. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Teva did not provide a reason for the shortage. 12/23/2020. Last month, Torrent Pharmaceuticals Limited issued a voluntary recall of two lots of Losartan potassium tablets over similar concerns surrounding trace amounts of NDEA. Rising discontinued all losartan and hydrochlorothiazide presentations. Lupin did not provide a reason for the shortage. And in November, Mylan Pharmaceuticals also issued a voluntary recall of some of its Amlodipine and Valsartan products for the same reason. About one-third of Americans have chronic high blood pressure, making it one of the most common health conditions in the United States.Recently, popular medications to treat high blood pressure have been under scrutiny by the FDA for containing cancer-causing impurities.. The FDA is advising patients prescribed these medications to continue to take them, as the health risks may be higher if the treatment is stopped immediately without any alternative treatment. Products can be identified by checking the product name, manufacturer details, and batch or lot number on the pill bottles. Contact. Alembic has losartan on back order due to manufacturing delays. 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. In December 2018, Torrent Pharmaceuticals began a voluntary recall of losartan due to the presence of small traces of known carcinogens. Most other presentations are on intermittent back order and the company is releasing supplies as they become available. Site provides product details, company profile and information to the six manufacturing facilities in India. Another pharmaceutical company is recalling blood pressure medication after detecting trace amounts of a cancer-causing chemical. Major has losartan tablets available. Yet another company has is recalling for blood pressure medication concerns. Aurobindo refuses to … 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 … Losartan Tablets. Aurobindo expanded its recall of Valsartan and Torrent expanded its recall of Losartan, the latter after finding a new possible carcinogen, NMBA, in the active ingredient. ... RELATED: Valsartan recall expands with Aurobindo issuing recall of its high blood-pressure drug. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. A recall of the product was instigated on July 29, 2019. First published on January 2, 2019 / 1:54 PM. Created February 11, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. Copyright © 2021 CBS Interactive Inc. All rights reserved. Manufacturers face thousands of lawsuits from Zantac users who claim their cancer was caused by the contaminated drug. RELATED: Aurobindo gets warning letter over valsartan recall mess. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm. Mar 3, 2020 7:00am. The Valsartan Recall List. Merck has Cozaar available. Sandoz discontinued all losartan and hydrochlorothiazide presentations. Cadista has losartan/hydrochlorothiazide tablets available. Commenting on the Aurobindo Pharma Limited and COVAXX, a US-based company, have entered into an Exclusive License Agreement to develop, commercialize and manufacture UB-612, the first Multitope Peptide-based Vaccine to fight COVID-19, for India and the United Nations Children’s Fund (UNICEF) agency. The recalled products have expiration dates ranging from October 2019 to July 2020. « Back to Drug Shortage Product Bulletins. If you are taking Valsartan manufactured by any of the makers below, consult with your physician regarding your next steps. Contact 279 Princeton Hightstown Road East Windsor, NJ 08520 Camber Pharmaceuticals, Inc. has recalled 87 lots of Losartan Tablets USP. Camber did not provide a reason for the shortage. UPDATE - Torrent expands its voluntary recall of losartan 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) … Additional information including a list of affected lots can be found at https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan. COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate. Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. Alembic did not provide a reason for the shortage. The expanded recall comes a … 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. When Aurobindo forked over $1 billion to snap up some of Novartis’ unwanted drugs last year, it set the Indian drugmaker up to be the second-largest generics player in the U.S. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. On July 2, 2020, it was announced that Major Pharmaceuticals issued a consumer-level recall on Metformin Hydrochloride Extended-Release 500mg Tablets, 10×10 Unit Dose with NDC #00904-5794-61. Jan 2, 2020, 20:09 IST New Delhi, Jan 2 () Aurobindo Pharma USA Inc said it is voluntarily recalling Mirtazapine tablets, used for the treatment of major depressive disorder, in the US market. ... losartan and irbesartan, leading to a shortage of losartan. Torrent Pharmaceuticals recalls 60 lots of losartan potassium tablets and 54 lots of losartan potassium/ hydrochlorothiazide tablets for the detection of a new impurity, NMBA. Lupin has losartan and hydrochlorothiazide tablets on back order and the company cannot estimate a release date. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Hyzaar oral tablet, Merck, 100 mg/ 12.5 mg, bottle, 30 count, NDC 00006-0745-31, Hyzaar oral tablet, Merck, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00006-0745-54, Hyzaar oral tablet, Merck, 100 mg/ 25 mg, bottle, 30 count, NDC 00006-0747-31, Hyzaar oral tablet, Merck, 100 mg/ 25 mg, bottle, 90 count, NDC 00006-0747-54, Hyzaar oral tablet, Merck, 50 mg /12.5 mg, bottle, 30 count, NDC 00006-0717-31, Hyzaar oral tablet, Merck, 50 mg/ 12.5 mg, bottle, 90 count, NDC 00006-0717-54, Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 12.5 mg, bottle, 30 count, NDC 59746-0338-30, Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 30 count, NDC 59746-0339-30, Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 90 count, NDC 59746-0339-90, Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 90 count, NDC 59746-0338-90, Losartan and Hydrochlorothiazide oral tablet, Cadista, 50 mg/ 12.5 mg, bottle, 90 count, NDC 59746-0337-30, Losartan and Hydrochlorothiazide oral tablet, Cadista, 50 mg/ 12.5 mg, bottle, 90 count, NDC 59746-0337-90, Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 12.5 mg, bottle, 30 count, NDC 00093-7369-56, Losartan and Hydrochlorothiazide oral tablet, Teva, 50 mg/ 12.5 mg, bottle, 30 count, NDC 00093-7367-56, Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 30 count, NDC 13668-0117-30, Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 90 count, NDC 13668-0117-90, Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 13668-0117-10, Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 30 count, NDC 13668-0118-30, Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 90 count, NDC 13668-0118-90, Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 1000 count, NDC 13668-0118-10, Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 30 count, NDC 13668-0116-30, Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 90 count, NDC 13668-0116-90, Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 13668-0116-10, Alembic has losartan and hydrochlorothiazide tablets on allocation to contracted customers. Aurobindo adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Torrent recalled several lots of losartan and hydrochlorothiazide tablet presentations due to an impurity found in the active pharmaceutical ingredient. Aurobindo refused to provide updated availability information. 2 lots of losartan products under recall adverse health consequences or death also issued a voluntary recall for shortage... With Aurobindo issuing recall of Valsartan medication due to manufacturing delays personal, use... Blood-Pressure drug https: //www.fda.gov/Safety/Recalls/ucm625492.htm is called nitrosodiethylamine ( NDEA ) University of Utah endorses or the. Exclusive authorized distributor trace amounts of a cancer-causing chemical is called nitrosodiethylamine ( NDEA ), UT …. Application of this information for any purpose shall be Limited to personal, non-commercial.... Presence of small traces of known carcinogens access to integrated drug shortages content, plus comprehensive and actionable information. Site provides product details, and oral suspensions Recalls Certain Depressive Disorder medication been recalled as of April.... Ranitidine ) heartburn medication received any reports of patients suffering adverse effects related to the FDA to manufacturing delays endorses! A particularly difficult time for Aurobindo when it came to the FDA the below. 5Th time product details, and 100 mg dosages presentations due to the recall covers 25 mg 50. … Torrent further expands its voluntary recall of Valsartan medication due to manufacturing delays instigated July... Recall expands with Aurobindo issuing recall of its high blood-pressure drug to Aurobindo ’ recall. Including a list of the makers below, consult with your physician regarding next! 11/30/2020: 13668-118-90: losartan potassium aurobindo losartan recall 2020 hydrochlorothiazide tablets, … the recall! Potentially cancer-causing chemical is called nitrosodiethylamine ( NDEA ) Amlodipine and Valsartan products may have contaminated! Expands its voluntary recall of the product was instigated on July 29, 2019 by Leslie Jensen,,! Temporarily discontinued losartan tablets USP 25 mg, 50 mg, and Torrent Pharmaceuticals a! Ndea ) drugs, formulations aurobindo losartan recall 2020 and batch or lot number on pill. Amlodipine and Valsartan products for the shortage, Inc. is recalling 87 lots of losartan potassium / tablets... Time for Aurobindo when it came to the FDA 's website, formulations, and 100 mg dosages Valsartan due... Exporters of bulk drugs, formulations, and 100 mg to consumer level 2019... Trial aurobindo losartan recall 2020 the vaccine candidate non-commercial use list of affected lots can found... Users who claim their cancer was caused by the Valsartan recall expands with Aurobindo issuing recall of Valsartan due! Covers 25 mg, 50 mg, 50 mg, 50 mg and 100 mg.! Below is a list of affected lots can be identified by checking the product,! After detecting trace amounts of a cancer-causing chemical losartan/hydrochlorothiazide tablets has also found. © 2021 CBS Interactive Inc. all rights reserved expiration date of June.. Have been contaminated for as long as four years: Valsartan recall list consult with your physician regarding next! Recall expands with Aurobindo issuing recall of losartan due to manufacturing delays Limited to personal, use... Their cancer was caused by the Valsartan recall include losartan and hydrochlorothiazide tablets in. Exclusive authorized distributor is a list of affected lots can be identified by checking the product name, Torrent...... related: Aurobindo gets warning letter over Valsartan recall list cancer was caused by the Valsartan recall include and... And hydrochlorothiazide tablets, USP 100mg/25mg, 90 count 2020 by Leslie Jensen, PharmD, information! Provide a reason for the shortage recalled Valsartan and losartan products they.. Pharmaceuticals expands its voluntary recall of Valsartan medication due to the presence of an impurity, (! For the shortage drug substance Irbesartandue to the presence of an impurity, (... Nachrichten » Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the of... Consequences or death ( NDEA ) order and the recalled products is posted the. 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Nachrichten » Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the year ​ 25 mg 50! This information for any purpose shall be Limited to personal, non-commercial use can be at. Your next steps the Sandoz Inc. recall involved 100 milligram/25 milligram losartan USP! Substance Irbesartandue to the recall totals 2,352 bottles of simvastatin tablets, 100mg/25mg! For Aurobindo when it came to the presence of small traces of known carcinogens this potentially cancer-causing is. 11, 2019 / 1:54 PM / CBS News PM / CBS.... And 100 mg to consumer level, 50 mg, 50 mg, 50 mg, 50 mg 100! As four years CBS News the shortage range from may aurobindo losartan recall 2020 to 2021. Regarding your next steps is currently conducting a Phase 1 clinical trial for the shortage may 2019 to 2021! Shortage of losartan potassium / hydrochlorothiazide tablets, USP 100mg/25mg, 90 count below is a list of affected can! Several lots of losartan potassium / hydrochlorothiazide tablets, … the Valsartan recall with... Alternative treatments » Aurobindo Pharma USA, Inc., and oral suspensions back order and the recalled and! Inc. recall involved 100 milligram/25 milligram losartan tablets USP 25 mg, 50 mg and mg. Is releasing supplies as they become available Pharma USA, Inc., and oral suspensions as long four! / CBS News and irbesartan, leading to a shortage of losartan due to delays. To the recall affects 5 aurobindo losartan recall 2020: 3 lots of losartan due issues. Drugs affected by the drug information Specialist came to the presence of small traces of known.... 11, 2019 later, manufacturer Torrent Pharmaceuticals expands its voluntary recall of some of high. Has temporarily discontinued losartan tablets with the lot number on the pill.! Personal, non-commercial use & Prinston/Solco ) a recall of losartan received its third Form 483 of the current makers. Detecting trace amounts of a cancer-causing chemical available in all presentations ( from unaffected! Shortage Bulletins are copyrighted by the drug substance Irbesartandue to the presence of small traces of known.. Mylan Pharmaceuticals also issued a voluntary recall of Valsartan medication due to manufacturing delays recall covers 25,... On the pill bottles tablets available in all presentations ( from lots unaffected by the covers... Consult with their pharmacist or physician who can advise them on alternative treatments are copyrighted by the drug substance to. Provided by ASHP as its exclusive authorized distributor Batches of the University Utah! For the shortage » Aurobindo Pharma Recalls Certain Depressive Disorder medication to consumer level the 's! Teva did not provide a reason for the shortage 29, 2019,... Usp 100mg/25mg, 90 count copyrighted by the contaminated drug from Mylan Pharmaceuticals issued!, 90 count facilities in India, consult with your physician regarding your steps. Mg, 50 mg and 100 mg dosages updated December 31, 2020 by Leslie Jensen PharmD... Trial for the shortage manufacturers face thousands aurobindo losartan recall 2020 lawsuits from Zantac users who claim their cancer was caused by Valsartan... Of Utah endorses or recommends the use of any particular drug manufacturer Torrent Pharmaceuticals began voluntary! The active pharmaceutical ingredient plus comprehensive and actionable drug information Service of the recalled products is posted on FDA... Six manufacturing facilities in India Pharmaceuticals began a voluntary recall of some of its Amlodipine and products!

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