Vivimed Life Sciences on May 3 announced a voluntary recall of 19 lots of losartan potassium tablets, making it the third company in two weeks to issue a recall of the blood pressure (BP) drug.
Vivimed made its announcement following the detection of trace amounts of N-methylnitrosobutric acid (NMBA) in certain batches of its losartan, which was manufactured by the company at its plant in Chennai, India, and distributed by Heritage Pharmaceuticals Inc., an East Brunswick, N.J., establishment. Vivimed maintains neither they nor Heritage have received any reports of adverse events linked to the recall.
The same goes for Teva Pharmaceuticals, Legacy Pharmaceutical Packaging and Torrent Pharmaceuticals, all companies that recently issued their own losartan recalls after finding higher-than-acceptable levels of NMBA in their BP-lowering products. All three named Hetero Labs Limited, a private company in India, as their source of tainted API (active pharmaceutical ingredient).
Vivimed’s recall affects tablets sold in 25 mg, 50 mg and 100 mg dosages and packaged in 90-count and 1,000-count bottles (find specific lot numbers here). The tabs were distributed nationwide to wholesalers, retail pharmacies, mail order pharmacies and other distributors, which are reportedly being notified of the recall.
Numerous companies have been recalling certain lots of angiotensin II receptor blockers (ARBs), including losartan, valsartan and irbesartan, since last July, when the FDA joined more than 20 other countries in recalling all medications containing tainted valsartan. All ARBs that have been recalled to date were withdrawn from the market due to trace amounts of probable carcinogens, including NMBA.
In late April, a lawyer told Bloomberg he expects these recalls will result in more than 2,000 lawsuits in the next couple of years.
For more coverage of recent ARB recalls, see below: