Drug Safety Alerts

Losartan Potassium 25mg, 50 mg, and 100 mg 10 x 10 unit dose Tablets distributed by Major Pharmaceuticals - Retail-level Recall

04/26/2019

On April 26, 2019, Major Pharmaceuticals issued a retail-level recall of Losartan Potassium 25mg, 50 mg, and 100 mg 10 x 10 unit dose tablets manufactured by Torrent Pharmaceuticals. This recall was issued 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 in the API is N-Methylnitrosobutyric acid (NMBA).

Note: This recall was originally issued on January 11, 2019. The recall was extended on April 26, 2019 to include additional products and lot numbers that were not part of the original notice.

A complete list of the affected products and lot numbers is provided here.

Losartan Potassium 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 should continue taking their medication until they receive a replacement product or a different medication to treat their condition, 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: These products are not carried by CVS Caremark Mail Service Pharmacies.

For more information about the recall, please call Major Pharmaceuticals toll-free at 1-800-616-2471. 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.