The recall covers 25 mg, 50 mg and 100 mg dosages. All 3 medicines contain losartan, an angiotensin II receptor blocker (ARB) commonly uused to treat hypertension. The recalled losartan and potassium/hydrochlorothiazide combination tablets contained small amounts of N-nitrosodiethylamine, or NDEA, according to a company notice posted to the Food and Drug Administration's website Wednesday. In December 2018, Torrent Pharmaceuticals began a voluntary recall of losartan due to the presence of small traces of known carcinogens. This product was distributed nationwide to distributors. Losartan Potassium was distributed by pharmacies nationwide. This product is … Related recalls 2020-12-22 - Certain Assala, Compliments, The Deli-Shop, and Levitts brands deli meat products recalled due to … Company Announcement. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. Now, almost a year later, manufacturer Torrent Pharmaceuticals expands its voluntary recall for the 5th time. Health care professionals advise patients to consult with their doctors or pharmacists before discontinuing one of the recalled blood pressure medicines or finding an alternative treatment. Sandoz is a global leader in generic pharmaceuticals and biosimilars. However, there has been one reported illness that may be associated with the consumption of the products included in the Food Recall Warning of December 7, 2020. There has been a recall on Metroprolol. Valsartan, Losartan & Irbesartan Recalled Due to Cancer Risk The U.S. Food and Drug Administration (FDA) is recalling a number of high blood pressure medications over potential cancer risks. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. (I was also on Cozaar and then Avapro). A total of 10 lots are now being recalled at the consumer level, including 2 recalled lots initially announced December 20, 2018. 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. They were manufactured by these drug companies: Over 2 million Americans received notices in the mail alerting them of … Sandoz has recalled one lot of losartan products made at its Lek Pharmaceuticals plant in Slovenia. Exit Full Screen. If you're concerned you may be taking recalled losartan, compare the information on your prescription drug label with the information in the table. Additionally, Legacy expanded its recall to include one additional lot of losartan tablets made with API manufactured by Hetero Labs. Finally, her doctor suggested valsartan from a manufacturer that has not been affected by recalls — but Brown said on Thursday that she’d learned even that lot of the drug had been recalled. Torrent Pharmaceuticals Ltd. has expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide 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. Recall of 3 brands of Losartan Medicines Frequently Asked Questions 1. Then my new coverage was not covering so doctor switched me to Coreg CR-80mg- it seemed to work, although BP was a little elevated. Originally the company recalled 10 lots of the medication. Torrent Pharmaceuticals Limited has expanded its recall of Losartan potassium tablets USP. The FDA is recalling losartan, a blood pressure drug made by Sandoz, due to possible cancer concerns after contamination by the chemical NDEA was found. This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Just … According to the FDA, NDEA occurs naturally in certain foods, drinking water, air pollution and industrial processes, and has been classified as a probable human carcinogen. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Torrent Pharmaceuticals voluntarily recalled two lots of losartan potassium tablets because of trace amounts of an impurity that has been found … What Losartan Has Been Recalled? 4 Losartan belongs to a class of medicines called angiotensin II receptor blockers (ARBs), which are used to treat high blood pressure, also known as hypertension. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. The FDA initiated what would become its largest class I drug recall to date in July 2018 and has since expanded the number of contaminated products involved. January 28, 2019 at 9:45 am EST By Natalie Dreier, Cox Media Group National Content Desk. There has been a recall on Metroprolol. Your healthcare provider has been advised to make arrangements to review and provide you with alternatives or other therapies. Losartan and irbesartan have also been recalled due to concerns that the high blood pressure medications are contaminated with nitrosamine impurities. Torrent and Hetero/Camber are only recalling lots of losartan-containing medication with NMBA above the interim acceptable intake limits of 0.96 parts per million (ppm). Of these, about 130,000 patients have been … Distributors and retailers that have product which is being recalled should immediately stop distribution of the identified lot above and quarantine any quantities remaining in your control and return the recalled product to the identified Reverse Distributor. Before sharing sensitive information, make sure you're on a federal government site. STOCK PHOTO/Getty Images. According to the FDA , about 300 lots of losartan and losartan/hydrochlorothiazide products have been recalled as of April 18, 2019. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. The active drug ingredient was manufactured at Hetero Labs Limited in India, one of the overseas drug factories linked to repeated blood medication recalls since last July. The recall is due trace amounts of an unexpected impurity, N-Methylnitrosobutyric acid (NMBA), detected during testing. Discontinuing a recalled drug could cause more immediate harm than staying on the medication. You should not place undue reliance on these statements. The recalled lots of Losartan were manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd., the same company that manufactured the NDMA -contaminated Valsartan. In addition to the three recalled brands, there are seven other brands of losartan medicines marketed in Singapore. Tests found trace amounts of … (I was also on Cozaar and then Avapro). Is it safe to take my Losartan by Lupin, the one mfg by Torrent has traces of some cancer causing substance. Camber Pharmaceuticals, Inc. has recalled 87 lots of Losartan Tablets USP. Camber Pharmaceuticals, Inc. has recalled 87 lots of Losartan Tablets USP. Only three of the ten losartan products in Singapore – Hyperten, Losagen and Losartas – contain the nitrosamine impurity. Instructions for returning recalled products are provided in … More Recalls, Market The recall has targeted losartan potassium tablets and losartan potassium/hydrochlorothiazide tablets. For questions about returning the product, contact Qualanex via email at [email protected] or call 888-280-2046 from 7 a.m. to 4 p.m. CST weekdays. Torrent is recalling 10 lots of losartan-containing products which have been found to contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels. 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. Losartan (blood pressure med) has been recalled by the FDA. 34 Related Question Answers Found Is losartan dangerous? 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