Vivimed Life Sciences is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg due to the detection of an impurity that is above the U.S. Food & Drug Administration’s limits.
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.
The impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – is above the U.S. Food & Drug Administration’s 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. To date, there have been no reports of adverse events related to this recall.
The product is made by Vivimed in Chennai, India and is distributed by Heritage Pharmaceuticals Inc, East Brunswick N.J.
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.
For a complete list of lots affected by the recall, please view the company press release.
Vivimed Life Sciences Pvt Ltd Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg, 50 mg and 100 mg Tablets, USP Due to the Detection of Trace Amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Impurity. Business Wire. (2019, May 6). Retrieved: https://www.businesswire.com/news/home/20190503005346/en