More Blood-Pressure Drugs Recalled Due to Cancer-Causing Impurities
In a year that has seen recall after recall for different ARBs, Mylan has announced a nationwide warning affecting more than 100 lots of medication.
The US Food and Drug Administration is warning of yet another recall of contaminated blood-pressure medications, this time a nationwide recall of all lots of valsartan-containing drugs—more than 100 lots in total. These include 26 lots of valsartan-amlodipine combination tablets, 27 lots of valsartan-hydrochlorothiazide combos, and 51 new lots of valsartan tablets, all made by Mylan Laboratories.
“Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the active pharmaceutical ingredient, valsartan,” an FDA alert stated Friday.
As previously reported by TCTMD, NDEA is a substance found in air pollution and various industrial processes, as well as some food. It is considered a possible human carcinogen by the International Agency for Research on Cancer (IARC).
Over the past year, valsartan, irbesartan, and losartan, made by a range of companies and manufactured in facilities in China and India, have been recalled due to contamination with NDEA and/or N-nitrosodimethylamine (NDMA), both of which are carcinogenic.
The latest alert notes that stand-alone amlodipine and hydrochlorothiazide are not affected by the recall.