More Losartan Added to Expanding Recall List, Heritage Pharma Distributors

May 06, 2019

Vivimed Life Sciences has issued a recall for 19 lots of its losartan potassium 25 mg, 50 mg, and 100 mg tabs distributed to wholesale, retail, and mail-order pharmacies by Heritage Pharmaceuticals.

They were found to contain unacceptable levels of the same potential carcinogen that has been detected in angiotensin-receptor blocker, or sartan, preparations from a number of companies, including most recently Teva Pharmaceuticals, Legacy Pharmaceutical Packaging, and Torrent Pharmaceuticals.

The affected Vivimed tablets, manufactured at the company's plant in Chennai, India, were found to contain levels of N-nitroso-N-methyl-4-aminobutyric acid (NMBA) greater than the acceptable exposure limit currently established by the US Food and Drug Administration (FDA), the company has announced on the agency's website.

The announcement contains lot numbers and the company's contact information, as well as instructions for reporting issues to Medwatch.

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

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