FDA does not endorse either the product or the company.Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (12 lots  of  50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 100mg/25mg strength) to the patient level due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Macleods Pharmaceuticals Limited is notifying its distributors and customers by phone and/or in writing to immediately discontinue distribution of the specific lot being recalled and to notify their sub-accounts. Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 … The company has recalled Losartan Potassium USP tablets and Losartan Potassium/Hydrochlorothiazide combination tablets, indicated to treat hypertension and hypertensive patients with Left … Recalls, Market Withdrawals, & Safety Alerts The drug was manufactured in India.Sign up for the Afternoon Update and get the day’s biggest stories in your inbox.This site is protected by reCAPTCHA and the Google Anyone with questions can contact Qualanex, which is handling the product returns for Macleods, via email at [email protected] or by phone at 888-280-2042, 8 a.m. to 5 p.m., Eastern time, Monday through Friday.Subscribe for unlimited digital access to the news that matters to your community. It’s lot No. Macleods Pharmaceuticals Limited has initiated a voluntary recall of 32 lots of drug products that contained API manufactured by Hetero Labs Limited , in the latest recall of angiotensin II receptor blocker (ARB) recalls. Macleods has issued a recall of 32 lots of drug products that contained trace amounts of NMBA impurities. The affected batches are below: Instructions for returning recalled products  are given in the recall letter.Consumers with medical questions regarding this recall or to report an adverse event can contact Macleods Pharmaceuticals Limited at 855-926-3384 (8:00 am - 5:00 pm EST).If you have any general questions regarding the return of this product, please contact Qualanex via email at recall@qualanex .com or call 888-280-2046 (7:00 am to 4:00 pm CST Monday to Friday).Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. There were also 152 resident deaths announced, bringing the toll closer to 13,000.Subscribe for unlimited digital access to the news that matters to your community. Patients who are on Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets, USP should continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.The products subject to recall are listed below and packaged in bottles. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Real-time updates and all local stories you want right in the palm of your hand. Macleods is arranging for return of all recalled products to Qualanex. Losartan Potassium USP tablets and Losartan Potassium/Hydrochlorothiazide combination tabletsAn official website of the United States government: The impurity was found in 32 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration's interim acceptable exposure limit of 9.82 ppm. He does not work Indianapolis 500 Race Day.

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