March 1, 2019 (AMN) — A recall of the blood pressure and heart failure medication Losartan has been expanded. The nationwide recall includes Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP.
The found impurity, N-Nitroso-N-methyl-4-aminobutyric acid or NMBA, is classified as a known animal carcinogen per US Food And Drug Administration noted in the FDA news release Friday about the recall.
Camber Pharmaceuticals Inc. voluntarily recalled 87 lots of losartan tablets in the United States on Thursday. The recalled tablets, made by Hetero Labs Ltd. In India and distributed by Camber Pharmaceuticals, were found to contain trace amounts of the impurity. Camber has not received any reports of adverse events related to the recall.
Torrent Pharmaceuticals Limited has advised the recall of 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP 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 known as N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA. Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall either.
Losartan is a common medication in the treatment of hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. 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. 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. The product can be identified by checking the product name, manufacturer details & batch or lot number on the bottle containing these products. Consumers may also call their pharmacies or physicians concerning any lot or batch numbers.
Any general questions regarding the return of this product should be directed to Qualanex at 1- 888-280-2040 (live calls received 8 am – 9:00 pm Eastern Time). FDA Recall Link (Click Here)