In December 2018, Torrent Pharmaceuticals began a voluntary recall of losartan due to the presence of small traces of known carcinogens. Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. This recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the losartan … COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate. A full list of the recalled products is posted on the FDA's website. If you are taking Valsartan manufactured by any of the makers below, consult with your physician regarding your next steps. Manufacturers and exporters of bulk drugs, formulations, and oral suspensions. If you are taking Valsartan manufactured by any of the makers below, consult with your physician regarding your next steps. 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. Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. Commenting on the Aurobindo adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. And in November, Mylan Pharmaceuticals also issued a voluntary recall of some of its Amlodipine and Valsartan products for the same reason. ... 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. 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Artikel bewerten: (1) Aurobindo … Cadista has temporarily discontinued losartan tablets due to issues with obtaining active ingredient. This potentially cancer-causing chemical is called nitrosodiethylamine (NDEA). 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. Updated December 31, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. Products Affected - Description. 12/23/2020. Contact. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm. Lupin and Sandoz did not provide a reason for the shortage. Copyright © 2021 CBS Interactive Inc. All rights reserved. In December 2018, Torrent Pharmaceuticals began a voluntary recall of losartan due to the presence of small traces of … 300 Leser. Torrent further expands its voluntary recall of losartan. Yet another company has is recalling for blood pressure medication concerns. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. 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. 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. 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. Rising discontinued all losartan and hydrochlorothiazide presentations. Some valsartan products may have been contaminated for as long as four years. The Valsartan Recall List. 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. Other recalls from Mylan Pharmaceuticals, Aurobindo Pharma USA, Inc., and Torrent Pharmaceuticals Limited followed. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT. A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Torrent further expands its voluntary recall of losartan. The expanded recall comes a … Expiration dates range from May 2019 to March 2021. Aurobindo refused to provide updated availability information; Cadista has losartan/hydrochlorothiazide tablets available. 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. Torrent has losartan and hydrochlorothiazide tablets available in all presentations (from lots unaffected by the recall). Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. Alembic has losartan on back order due to manufacturing delays. Another pharmaceutical company is recalling blood pressure medication after detecting trace amounts of a cancer-causing chemical. 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. NDMA has also been found in Zantac (ranitidine) heartburn medication. Rising discontinued all losartan and hydrochlorothiazide presentations. Most other presentations are on intermittent back order and the company is releasing supplies as they become available. Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartandue to the presence of an impurity, N-nitrosodiethylamine (NDEA). Products can be identified by checking the product name, manufacturer details, and batch or lot number on the pill bottles. Last year was a particularly difficult time for Aurobindo when it came to the FDA. Site provides product details, company profile and information to the six manufacturing facilities in India. Major has losartan tablets available. 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. 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. However, patients should consult with their pharmacist or physician who can advise them on alternative treatments. Any application of this information for any purpose shall be limited to personal, non-commercial use. 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. Camber Pharmaceuticals, Inc. has recalled 87 lots of Losartan Tablets USP. ... RELATED: Valsartan recall expands with Aurobindo issuing recall of its high blood-pressure drug. Other drugs affected by the valsartan recall include losartan and irbesartan. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Lupin did not provide a reason for the shortage. 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. Teva did not provide a reason for the shortage. Nachrichten » Aurobindo Pharma Recalls Certain Depressive Disorder Medication. The Valsartan Recall List. A recall of the product was instigated on July 29, 2019. The recall totals 2,352 bottles of simvastatin tablets, … 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. Sandoz discontinued all losartan and hydrochlorothiazide presentations. Camber did not provide a reason for the shortage. Contact 279 Princeton Hightstown Road East Windsor, NJ 08520 Manufacturers face thousands of lawsuits from Zantac users who claim their cancer was caused by the contaminated drug. Lupin has losartan and hydrochlorothiazide tablets on back order and the company cannot estimate a release date. 02.01.2020 | 13:49. Aurobindo refused to provide updated availability information. 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. 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. Hydrochlorothiazide tablets available in all presentations ( from lots unaffected by the contaminated drug CBS Interactive Inc. all reserved... Exporters of bulk drugs, formulations, and batch or lot number the! Tablets available in all presentations ( from lots unaffected by the drug will cause serious health... Fda alerts patients and health care professionals to Aurobindo ’ s recall of its blood-pressure! 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