logo
Plus   Neg
Share
Email

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.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
BHP Billiton plc (BHP.AX, BLT.L, BBL, BHP) reported a profit for the year ended 30 June 2018 that declined 37 percent from last year, reflecting massive write-down on its US onshore oil and gas assets, US tax reform and the ongoing fallout from its Brazilian dam collapse. But, underlying attributable profit increased 33%, supported by 8% Group copper equivalent volume growth. Luxury online marketplace Farfetch has filed for an initial public offering or IPO to list its shares in the U.S. Farfetch has filed a F-1 registration statement with the U.S. Securities and Exchange Commission. The London-based company plans to list its shares on the New York Stock Exchange under the ticker 'FTCH.' Media reports indicate that IPO could value the company at up to $5 billion. Apple Inc. has reportedly removed more than 25,000 illegal apps from its App Store in China after coming under intense criticism from Chinese state media for failing to ban illegal online content on its platform. According to various media reports, the iPhone maker removed these illegal apps as they sold fake lottery tickets and offered gambling services.
Follow RTT