Vivimed Life Sciences recalls Losartan Potassium tabs due to cancer-causing ingredient

Vivimed Life Sciences Pvt Ltd (Vivimed), located in India, is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level, reports the Food and Drug Administration. Losartan Potassium Tablets, indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients, were distributed nationwide to wholesalers, distributors, retail pharmacies, and mail order pharmacies.

The detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – is above the FDA’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, said the company in its letter. The product is distributed by Heritage Pharmaceuticals Inc, East Brunswick, NJ. Neither company has reported adverse events related to the recall but pharmacies and healthcare facilities that have the product being recalled from these listed lots should stop using and dispensing the product immediately.

Losartan Potassium is packaged in 90-count and 1000-count bottles. The identifying NDC #s associated with Heritage distributed product are as follows:

·   Losartan Tablets, 25 mg, 90-count: NDC 23155-644-09

·   Losartan Tablets, 50 mg, 90-count: NDC 23155-645-09; 1000-count: NDC 23155-645-10

·   Losartan Tablets, 100 mg, 90-count: NDC 23155-646-09; 1000-count: NDC 23155-646-10