Instructions for returning recalled products are given in the recall letter.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.June 26, 2019 -- Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. He enjoys running marathons and showing off about running marathons. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.Losartan Potassium tablets, USP and Losartan Potassium / Hydrochlorothiazide tablets, USP were distributed nationwide to Torrent's wholesale distributor, repackager and retail customers.
Consumers should 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.Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). For the latest FDA MedWatch alerts, The warning letter outlines several current good manufacturing practice (CGMP) deviations at this Mylan facility, including failure to have adequate written procedures for the receipt, identification and handling of raw materials and failure to adequately clean equipment and utensils. OTTAWA – Health Canada is advising Canadians that multiple lots of Losartan-containing drugs are being voluntarily recalled by Teva Canada, Apotex Inc., Pharmascience Inc., and Pro Doc Limitée because of the potential for a nitrosamine impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The agency continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-Nitrosodimethylamine (NDMA) and is taking swift action when it identifies these impurities that are above acceptable levels.FDA has updated lists of valsartan products under recall and valsartan products not under recall. Instructions for returning recalled products are given in the recall letter.1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).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.Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. The identifying NDC numbers associated with Legacy’s product are as follows:The affected Losartan Potassium includes 40 repackaged lots numbers which are listed below:The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.Losartan Potassium was distributed by pharmacies nationwide.