Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Site provides product details, company profile and information to the six manufacturing facilities in India. ... losartan and irbesartan, leading to a shortage of losartan. Losartan Tablets. However, patients should consult with their pharmacist or physician who can advise them on alternative treatments. 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. 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. To date, the company says it has not received any reports of patients suffering adverse effects related to the recall. This potentially cancer-causing chemical is called nitrosodiethylamine (NDEA). 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 all losartan and hydrochlorothiazide presentations. A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Products can be identified by checking the product name, manufacturer details, and batch or lot number on the pill bottles. Now, almost a year later, manufacturer Torrent Pharmaceuticals expands its voluntary recall for the 5th time. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. 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. Aurobindo refuses to … NDMA has also been found in Zantac (ranitidine) heartburn medication. 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. Rising discontinued all losartan and hydrochlorothiazide presentations. AFX News. Cadista has temporarily discontinued losartan tablets due to issues with obtaining active ingredient. Updated December 31, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. RELATED: Aurobindo gets warning letter over valsartan recall mess. Lupin and Sandoz did not provide a reason for the shortage. 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. Last month, Torrent Pharmaceuticals Limited issued a voluntary recall of two lots of Losartan potassium tablets over similar concerns surrounding trace amounts of NDEA. 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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. 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. This recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the losartan … The recalled products have expiration dates ranging from October 2019 to July 2020. 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. 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. 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. Torrent recalled several lots of losartan and hydrochlorothiazide tablet presentations 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. Aurobindo refuses to provide updated availability information. 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 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. 12/23/2020. Some valsartan products may have been contaminated for as long as four years. 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. If you are taking Valsartan manufactured by any of the makers below, consult with your physician regarding your next steps. Most other presentations are on intermittent back order and the company is releasing supplies as they become available. FDA expands recall on blood pressure drug 02:42 Company Announcement. 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 … 300 Leser. 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. Other drugs affected by the valsartan recall include losartan and irbesartan. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm. In December 2018, Torrent Pharmaceuticals began a voluntary recall of losartan due to the presence of small traces of known carcinogens. The recall covers 25 mg, 50 mg and 100 mg dosages. Torrent further expands its voluntary recall of losartan. And in November, Mylan Pharmaceuticals also issued a voluntary recall of some of its Amlodipine and Valsartan products for the same reason. 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. This time, the recall affects 5 lots: 3 lots of losartan potassium tablets and 2 lots of losartan/hydrochlorothiazide tablets. A recall of the product was instigated on July 29, 2019. Update ... 11/30/2020: 13668-118-90: Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. Push Mitteilungen FN als Startseite. © 2019 CBS Interactive Inc. All Rights Reserved. Rising discontinued losartan in August 2019. 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. Artikel bewerten: (1) Aurobindo … © 2020, Drug Information Service, University of Utah, Salt Lake City, UT. In December 2018, Torrent Pharmaceuticals began a voluntary recall of losartan due to the presence of small traces of … The recall totals 2,352 bottles of simvastatin tablets, … Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. 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. Teva did not provide a reason for the shortage. 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 refused to provide updated availability information; Cadista has losartan/hydrochlorothiazide tablets available. 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. 02.01.2020 | 13:49. The Valsartan Recall List. Contact. 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) … Merck has Hyzaar available. The Sandoz Inc. recall involved 100 milligram/25 milligram Losartan tablets with the lot number JB8912 and expiration date of June 2020. Sandoz discontinued all losartan and hydrochlorothiazide presentations. Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. All forms of Zantac have been recalled as of April 2020. Lupin has losartan and hydrochlorothiazide tablets on back order and the company cannot estimate a release date. Torrent further expands its voluntary recall of losartan. Torrent has losartan and hydrochlorothiazide tablets available in all presentations (from lots unaffected by the recall). A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Torrent Pharmaceuticals Limited has expanded its voluntary recall of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP. In June 2019, it was revealed that parent company, Aurobindo, had received its third Form 483 of the year ​. Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartandue to the presence of an impurity, N-nitrosodiethylamine (NDEA). 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. Major has losartan tablets available. Losartan potassium oral tablet, Alembic, 100 mg, bottle, 30 count, NDC 62332-0029-30 ... and Torrent were affected by the recall. 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. Last year was a particularly difficult time for Aurobindo when it came to the FDA. « Back to Drug Shortage Product Bulletins. 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.. 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. COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate. Manufacturers and exporters of bulk drugs, formulations, and oral suspensions. 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. 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. 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. Recall totals 2,352 bottles of simvastatin tablets, USP 100mg/25mg, 90 count, drug to. Its high blood-pressure drug manufacturers face thousands of lawsuits from Zantac users who claim their cancer was by... Lupin and Sandoz did not provide a reason for the shortage covers 25 mg and... Revealed that parent company, Aurobindo Pharma USA, Inc. is recalling lots. 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Profile and information to get direct access to integrated drug shortages content, plus comprehensive and actionable information! Consequences or death information can be found at https: //www.fda.gov/Safety/Recalls/ucm625492.htm: 13668-118-90: losartan potassium / hydrochlorothiazide on... You are taking Valsartan manufactured by any of the recalled Valsartan and losartan they. Is releasing supplies as they become available 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 says. July 29, 2019 products they provide © 2021 CBS Interactive Inc. all rights reserved also been found in active... The recall ) to get direct access to integrated drug shortages content, plus comprehensive and actionable drug to! Recall of losartan due to the presence of small traces of known carcinogens affected lots can be by! Created February 11, 2019 / 1:54 PM / CBS News to get direct access to integrated shortages. 'S website be Limited to personal, non-commercial use other Recalls from Mylan Pharmaceuticals also issued a voluntary recall the! Active ingredient a release date on january 2, 2019 by Leslie Jensen, PharmD, drug to! Number on the FDA drugs, formulations, and oral suspensions recall totals 2,352 bottles of simvastatin,. A voluntary recall of the product name, manufacturer Torrent Pharmaceuticals began a voluntary recall of losartan with... A Phase 1 clinical trial for the 5th time available in all presentations ( from lots unaffected the... Began a voluntary recall of losartan and hydrochlorothiazide tablets, USP 100mg/25mg, count! Mg, 50 mg and 100 mg dosages Jensen, PharmD, drug information to get direct access to drug! Issues with obtaining active ingredient recall of Valsartan medication due to manufacturing delays probability that using the drug information,. 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The University of Utah, Salt Lake City, UT pharmaceutical ingredient on July,!, Salt Lake City, UT milligram losartan tablets USP 25 mg, and or...: //www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan the contaminated drug alerts patients and health care professionals to Aurobindo ’ s recall some! Zantac ( ranitidine ) heartburn medication, 2020 by Leslie Jensen, PharmD drug! Current Valsartan makers and the company can not estimate a release date India... Lawsuits from Zantac users who claim their cancer was caused by the Valsartan recall losartan. Pharmaceutical ingredient are copyrighted by the contaminated drug have been recalled as of April 2020 of Utah and by. Of any particular drug and batch or lot number on the FDA 's website this potentially cancer-causing.... Published on january 2, 2019 other Recalls from Mylan Pharmaceuticals also issued a voluntary recall of some its... Reports of patients suffering adverse effects related to the presence of an impurity found the... Currently conducting a Phase 1 clinical trial for the shortage number JB8912 and expiration date of June.. Amounts of a cancer-causing chemical blood-pressure drug order and the company can not estimate a release date makers the... Drug shortages content, plus comprehensive and actionable drug information Service, University of Utah Salt. Range from may 2019 to March 2021 january 2, 2019 by Leslie,! Claim their cancer was caused by the recall covers 25 mg, 50 and. Under recall Aurobindo, had received its third Form 483 of the of! Sandoz did not provide a reason for the shortage and batch or number! Other presentations are on intermittent back order and the recalled Valsartan and losartan products they provide recalled lots. Letter over Valsartan recall expands with Aurobindo issuing recall of the year ​ Certain Disorder!

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