Aurobindo refuses to provide updated availability information. 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. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, … Cadista has losartan/hydrochlorothiazide tablets available. 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. Losartan Tablets. Teva 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. NDMA has also been found in Zantac (ranitidine) heartburn medication. 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 … A full list of the recalled products is posted on the FDA's website. 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. 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. Most other presentations are on intermittent back order and the company is releasing supplies as they become available. Major has losartan 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. The recall covers 25 mg, 50 mg and 100 mg dosages. Any application of this information for any purpose shall be limited to personal, non-commercial use. ... RELATED: Valsartan recall expands with Aurobindo issuing recall of its high blood-pressure drug. Alembic has losartan on back order due to manufacturing delays. Company Announcement. 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. 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.". / CBS News. Rising discontinued all losartan and hydrochlorothiazide presentations. Commenting on the 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. Torrent further expands its voluntary recall of losartan. Cadista has temporarily discontinued losartan tablets due to issues with obtaining active ingredient. Torrent recalled several lots of losartan and hydrochlorothiazide tablet presentations due to an impurity found in the active pharmaceutical ingredient. If you are taking Valsartan manufactured by any of the makers below, consult with your physician regarding your next steps. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm. In June 2019, it was revealed that parent company, Aurobindo, had received its third Form 483 of the year ​. Torrent Pharmaceuticals Limited has expanded its voluntary recall of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP. Site provides product details, company profile and information to the six manufacturing facilities in India. The recall totals 2,352 bottles of simvastatin tablets, … Aurobindo refused to provide updated availability information. Created February 11, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. ... losartan and irbesartan, leading to a shortage of losartan. AFX News. Lupin did not provide a reason for the shortage. 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. 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. Yet another company has is recalling for blood pressure medication concerns. January 2, 2019 / 1:54 PM Now, almost a year later, manufacturer Torrent Pharmaceuticals expands its voluntary recall for the 5th time. © 2019 CBS Interactive Inc. All Rights Reserved. Last month, Torrent Pharmaceuticals Limited issued a voluntary recall of two lots of Losartan potassium tablets over similar concerns surrounding trace amounts of NDEA. 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.. Contact. All forms of Zantac have been recalled as of April 2020. Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. 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. 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. Copyright © 2021 CBS Interactive Inc. All rights reserved. FDA expands recall on blood pressure drug 02:42 Updated December 31, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. Torrent further expands its voluntary recall of losartan. Update ... 11/30/2020: 13668-118-90: Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. 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. Manufacturers and exporters of bulk drugs, formulations, and oral suspensions. Click here for an updated list of Losartan products under recall. First published on January 2, 2019 / 1:54 PM. 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. Three additional lots of losartan potassium tablets and two additional lots of losartan potassium/hydrochlorothiazide tablets were under recall, the U.S. Food … A recall of the product was instigated on July 29, 2019. Another pharmaceutical company is recalling blood pressure medication after detecting trace amounts of a cancer-causing chemical. A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) The Valsartan Recall List. 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. Camber Pharmaceuticals, Inc. has recalled 87 lots of Losartan Tablets USP. 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. 12/23/2020. 300 Leser. Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. RELATED: Aurobindo gets warning letter over valsartan recall mess. Other drugs affected by the valsartan recall include losartan and irbesartan. Last year was a particularly difficult time for Aurobindo when it came to the FDA. Camber did not provide a reason for the shortage. The recalled products have expiration dates ranging from October 2019 to July 2020. The expanded recall comes a … 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. Mar 3, 2020 7:00am. 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. 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. 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. Alembic did not provide a reason for the shortage. « Back to Drug Shortage Product Bulletins. A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) 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. Expiration dates range from May 2019 to March 2021. Sandoz discontinued all losartan and hydrochlorothiazide presentations. Contact 279 Princeton Hightstown Road East Windsor, NJ 08520 Rising discontinued losartan in August 2019. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. 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