Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium/ Hydrochlorothiazide Tablets, USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Shortage reports. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.The products subject to recall are listed below and packaged in bottles. With this recall, Teva has now recalled all their unexpired valsartan-containing products from the U.S. market.The agency continues to investigate and test all angiotensin II receptor blocker (ARBs) for the presence of NDMA and NDEA and is taking swift action when it identifies these impurities that are above acceptable levels.FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall. In fact, we issued guidance in early 2018 to provide information to manufacturers regarding their responsibilities to assess the risks and implement appropriate controls for their manufacturing process. Failure to correct these violations may result in further action by the agency. Torrent is arranging for return of all recalled products to Qualanex. This recall … Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years. We’re also committed to communicating as transparently as possible. FDA continues to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities. The agency will use the interim limits to recommend manufacturers conduct a voluntary recall if laboratory testing confirms the presence of nitrosamine impurities in finished drug product. Upon detection of NDEA in valsartan products manufactured by Zhejiang Huahai Pharmaceuticals, FDA redeveloped the testing method so that it can be used to detect and quantify levels of both NDMA and NDEA. Macleods is arranging for return of all recalled products to Qualanex. FDA will determine, on a case-by-case basis, whether lots containing NMBA greater than 0.96 ppm should be released for distribution.FDA reminds patients taking recalled angiotensin II receptor blockers (ARBs) to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition.Additionally, Legacy expanded its recall to include one additional lot of losartan tablets made with API manufactured by Hetero Labs.Manufacturers should contact FDA’s Drug Shortages Staff when their testing of losartan shows levels of NMBA that exceed the interim acceptable intake limit of 0.96 ppm. * The acceptable intake is a daily exposure to a compound such as NDMA or NDEA that results in a 1:100,000 cancer For comparison with the levels of NDMA found in some common foods, please see our Aug. 20, 2018, The agency also updated the list of valsartan products under recall and the list of valsartan products not under recall.Teva is recalling all lots of amlodipine and valsartan combination tablets and amlodipine, valsartan, and hydrochlorothiazide (HCTZ) combination tablets due to the presence of N-Nitrosodiethylamine (NDEA).