The FDA says an additional recall has been issued for certain blood pressure medicines due to trace amounts of a cancer-causing chemical.
According to the FDA’s website, Aurobindo Pharma USA is voluntarily recalling two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient.
According to the National Institutes of Health, NDEA is a suspected human and animal carcinogen that is used in gasoline as a stabilizer for industry materials and as a lubricant additive, according to the National Institutes of Health.
Aurobindo is recalling amlodipine and HCTZ only in combination medications containing valsartan. Neither amlodipine nor HCTZ is currently under recall by itself.
Aurobindo is recalling lots of valsartan-containing medication that tested positive for NDEA above the interim acceptable daily intake level of 0.083 parts per million.
The FDA says patients taking any recalled ARB should continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. Some ARBs contain no NDMA or NDEA.
Also in December 2018, Losartan, a similar ARB was recalled by the manufacturing company Torrent Pharmaceutical Limited. Two lots of Losartan were recalled due to the same carcinogen, NDEA.
Call and ask your doctor or pharmacist to check and see if your medication was effected by the voluntary recall.