NEW YORK (CBSNewYork/CBS) – The maker of a popular drug used to control hypertension and high blood pressure is expanding its recall on the medicine after trace amounts of an impurity were detected.
Torrent Pharmaceuticals announcement includes an additional three lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.
The expansion is the fifth by Torrent involving widely used losartan potassium tablets sold nationwide at retailers including Walmart. Regulators first moved to pull heart drugs with potentially deadly contaminants from store shelves last year.
The contaminant behind the latest Torrent recall is also the same one that prompted Novartis to halt the distribution of generic versions of the popular heartburn drug Zantac earlier in the week.
Torrent on Thursday said it was recalling an additional five lots of medication used to treat hypertension after the discovery in the tablets of a chemical called NMBA (for N-Nitroso-N-methyl-4-aminobutyric acid).
The U.S. Food and Drug Administration for the past 14 months has overseen a slew of recalls for a type of generic blood-pressure medication produced in China and India and tainted with NMBA, NDMA (N-nitrosodimethylamine) or NDEA (N-nitrosodiethylamine.)
The FDA has said the impurities in the generic blood pressure pills known as ARB drugs (for angiotensin II receptor blocker drugs) may be the result of chemical reactions that occur in the manufacturing process or from the reuse of materials such as solvents.
If 8,000 people took the highest dose from recalled batches every day for four years, there would likely be one additional case of cancer over the life of those people, the agency estimates.
Torrent said it’s only recalling lots containing NMBA above what the FDA considers acceptable for daily use. Overall, Torrent has recalled more than 300 lots of blood-pressure pills since the summer of 2018. It’s among a dozen drugmakers that have recalled blood-pressure drugs made with active ingredients from suppliers in China and India.
Other companies to announce recalls include Mylan, Aurobindo Pharma, Camber Pharmaceuticals, Macleods Pharmaceuticals, Legacy Pharmaceuticals, GSMS Inc., WP Westminster Pharmaceuticals, Major Pharmaceuticals, Prinston Pharmaceuticals, Sandoz Novartis and Teva Pharmaceuticals.
Consumers with questions about the losartan recall can contact Torrent Pharmaceuticals Limited at 1-800-912-9561 between 8:00 a.m. to 5:00 p.m. ET, or leave a voicemail at any time, or email Medinfo.Torrent@apcerls.com.
For more information, see the FDA.gov website.