Drug Safety Alerts

Losartan potassium and Losartan potassium and hydrochlorothiazide Tablets - Consumer-level Recall

02/28/2019

On February 28, 2019, Torrent issued a consumer-level recall of losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets. This recall was issued due to the detection 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).

A complete list of the affected products is provided at the end of this here:

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Patients who are on losartan potassium and hydrochlorothiazide tablets 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.

CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets to contact their prescriber.

For more information, please contact Torrent Pharma Inc. at 1-800-912-9561, 8:00 am to 5:00 pm (ET). You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.