When Aurobindo Pharma USA Inc. issued a recall of 80 lots of Amlodipine Valsartan USP, Valsartan HCTZ USP, and Valsartan USP tablets on December 31, it was just the latest blood pressure medicine recall in the past three months.
According to the US Food and Drug Administration, since October 26, 2018, there have been 8 nationwide recalls of medications due to the presence of the same impurity found in the active pharmaceutical ingredient used in the creation of the drugs that are routinely prescribed to treat hypertension and heart failure.
NDEA (N-Nitrosodiethylamine) is the common denominator in the recall cases for drugs produced by produced by Auribindo, Torrent Pharmaceuticals Limited, Mylan Pharmaceuticals, Teva Pharmaceuticals, Sandoz Inc. (brand name Losartan), and ScieGen Pharmaceuticals, Inc. (brand names Westminister Pharmaceuticals and Golden State Medical Supply).
NDEA occurs naturally in certain foods, drinking water, air pollution, tobacco smoke, and industrial processes, and has been classified as a probable human carcinogen by the International Agency for Research on Cancer. The compound is primarily used as a research chemical but, according to the Environmental Protection Agency, has been used in the past as an antioxidant as well as in the production of rocket fuels.
While trace amounts of NDEA should not pose a threat, acute exposure to NDEA may cause liver damage in humans.
So far, none of the drug companies have received any reports of adverse effects from use of the recalled drugs and the FDA recommends patients contact their doctors for possible alternative treatments.
A complete list of drug recalls, including batch numbers and drug names can be found at www.fda.com/drugs/drugsafety/drugrecalls. You can filter your search using the keyword "NDEA" to find individual company recall details, including lot numbers, product photos and company contacts.
