Drug Safety Alerts

Losartan Potassium Tablets Consumer-Level Recall Expanded

12/20/2018

On December 20, 2018, Torrent issued a consumer-level recall of losartan potassium 100 mg tablets. On January 3, 2019, Torrent expanded the recall by adding additional lots of losartan potassium 100 mg tablets and additional strengths to include losartan potassium 25 mg tablets and losartan potassium 50 mg 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-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

A complete list of the affected products is provided here:

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

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 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 Mail Service Pharmacy is contacting patients and prescribers to advise them of this expanded recall. We are encouraging patients who are taking losartan potassium tablets to contact their prescriber.

For more information about this recall, health care providers may 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.