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US Food and Drug Administration Announces Recall of Several Drugs Containing Valsartan
The FDA has announced the voluntary recall of several drugs containing the active ingredient Valsartan, used to treat high blood pressure and heart failure.
The United States Food and Drug Administration has stated that Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. recalls all lots of valsartan tablets, 40 mg, 80 mg, 160 mg and 320 mg; and Valsartan-Hydrochlorothiazide Tablets, 80 mg / 12.5 mg, 160 mg / 12.5 mg, 160 mg / 25 mg, 320 mg / 12.5 mg and 320 mg / 25 mg at retail.
FDA has announced the voluntary recall of several pharmaceutical products containing the active ingredient valsartan, used to treat hypertension and heart failure.
FDA said the recall is due to the detection of a trace of an unexpected impurity, N-nitrosodimethylamine (NDMA), manufactured by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. This impurity has been clbadified as a probable human carcinogen according to the clbadification of the International Agency for Research on Cancer (IARC)
The US recall includes versions of valsartan that are manufactured by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. . and valsartan / hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.
"We have carefully evaluated drugs containing valsartan sold in the United States., And we found that the Valsartan sold by these specific companies does not meet our safety standards," said Janet Woodbad, director of Dans. a release, the FDA Drug Evaluation and Research Center
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