logo
  

FDA Announces Voluntary Recall Of Valsartan Following Detection Of Impurity

The Food and Drug Administration said that Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level.

FDA announced voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.

FDA said that the recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer - Zhejiang Huahai Pharmaceutical Co. Ltd. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

The US recall includes the the versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. as well as valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

"We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement.


Now, let's have a look at the RTT video on Valsartan recall.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Integrated energy company Chevron reported Friday that profit for the fourth quarter increased 25 percent from last year, reflecting 17 percent revenue growth amid higher realizations and higher margins on refined product sales. Adjusted earnings per share missed analysts' estimates, while quarterly revenues topped it. Reno, Nevada-based ZLINE Kitchen and Bath has expanded its recall of gas ranges citing serious risk of injury or death from carbon monoxide poisoning, the U.S. Consumer Product Safety Commission announced. The recall now includes about 30,000 units of ZLINE gas ranges, including about 28,000 units... The Food and Drug Administration's independent advisory committee unanimously recommended replacing the current original COVID vaccines used in the U.S. for primary shots with new bivalent omicron shots authorized as boosters, reports said. The committee also considered the proposal for annual COVID vaccination, however, didn't vote on it.
Follow RTT