Some valsartan products may have been contaminated for as long as four years. Subscribe to AHFS Clinical Drug Information to get direct access to integrated drug shortages content, plus comprehensive and actionable drug information. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. Aurobindo adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Camber did not provide a reason for the shortage. Manufacturers face thousands of lawsuits from Zantac users who claim their cancer was caused by the contaminated drug. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, … Three additional lots of losartan potassium tablets and two additional lots of losartan potassium/hydrochlorothiazide tablets were under recall, the U.S. Food … Teva did not provide a reason for the shortage. Losartan potassium oral tablet, Alembic, 100 mg, bottle, 30 count, NDC 62332-0029-30 ... and Torrent were affected by the recall. AFX News. In June 2019, it was revealed that parent company, Aurobindo, had received its third Form 483 of the year ​. COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate. To date, the company says it has not received any reports of patients suffering adverse effects related to the recall. Major has losartan tablets available. 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. 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. 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. A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. Lupin did not provide a reason for the shortage. ... losartan and irbesartan, leading to a shortage of losartan. Click here for an updated list of Losartan products under recall. 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.". Site provides product details, company profile and information to the six manufacturing facilities in India. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm. 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 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. Created February 11, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. Camber Pharmaceuticals, Inc. has recalled 87 lots of Losartan Tablets USP. A full list of the recalled products is posted on the FDA's website. The recall totals 2,352 bottles of simvastatin tablets, … Artikel bewerten: (1) Aurobindo … © 2020, Drug Information Service, University of Utah, Salt Lake City, UT. 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. 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. FDA expands recall on blood pressure drug 02:42 This time, the recall affects 5 lots: 3 lots of losartan potassium tablets and 2 lots of losartan/hydrochlorothiazide tablets. NDMA has also been found in Zantac (ranitidine) heartburn medication. 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. Other drugs affected by the valsartan recall include losartan and irbesartan. Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. Aurobindo refuses to provide updated availability information. Merck has Cozaar available. Last month, Torrent Pharmaceuticals Limited issued a voluntary recall of two lots of Losartan potassium tablets over similar concerns surrounding trace amounts of NDEA. 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. 300 Leser. 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.. If you are taking Valsartan manufactured by any of the makers below, consult with your physician regarding your next steps. Torrent further expands its voluntary recall of losartan. Merck has Hyzaar available. 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. Torrent Pharmaceuticals Limited has expanded its voluntary recall of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP. 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. 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. 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. The Sandoz Inc. recall involved 100 milligram/25 milligram Losartan tablets with the lot number JB8912 and expiration date of June 2020. 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