Drug Safety Alerts

Vivimed Life Sciences Losartan Potassium Tablets Consumer-Level Recall

05/03/2019

On May 3, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level Recall of Losartan Potassium Tablets 25mg, 50 mg, and 100 mg manufactured by Vivimed Life Sciences Pvt Ltd (Vivimed) and distributed by Heritage Pharmaceuticals Inc. This recall was issued due to detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out. 

A complete list of the affected products is provided here:

Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles.

Patients who are on Losartan Potassium 25 mg, 50 mg, or 100 mg 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.

To date, neither Vivimed nor Heritage has received any reports of adverse events related to this recall.

CVS Caremark Response:

Please note: The Losartan Potassium 25 mg, 50 mg, and 100 mg tablets manufactured by Vivimed Life Sciences and distributed by Heritage Pharmaceuticals Inc. are not carried by CVS Caremark Mail Service Pharmacies.

For more information about this recall, please contact Vivimed C/o Inmar at 1-877-861-3811. You may also contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.