For the third time in per week, and fifth time in two weeks, a company is recalling a preferred blood pressure medication after discovering trace quantities of a probably cancer-causing impurity.
American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg. It is available in 100-count blisters with so much variety of 179791 and an expiration date of March 31, 2020. This recall is being initiated in response to a recall by the producer, Aurobindo Pharma USA, which included the affected lot that was repackaged by American Health Packaging.
The preliminary Aurobindo recall for Valsartan was on Dec. 31, 2018, and expanded on March 1.
The impurity is N-Nitrosodiethylamine (NDEA). It’s one in all three impurities present in a number of blood stress drugs since July 2018 which generally is a potential human carcinogen.
Patients utilizing Valsartan are suggested to maintain taking it till they’ll discuss to their physician about options. Discontinuing use may additionally pose health dangers.
There have been 5 such recalls since Feb. 22. Three of them had been for detection of NDEA and two had been for N-Methylnitrosobutyric acid (NMBA). The opposite possible human carcinogen present in blood pressure medicine since July is N-nitrosodimethylamine (NDMA).
There have been at the least 21 recalls, or expansions of recalls, involving blood stress medication for possible cancer-causing impurities since July 13, 2018.
The FDA mentioned the impurities is likely to be occurring when particular chemical compounds and response situations are current within the manufacturing process of the drug’s API (active pharmaceutical components). It could additionally end result from the reuse of supplies, resembling solvents.