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.

For comments and feedback contact: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Bahrain's foreign minister has called for a boycott of Uber after the ride-hailing company's Chief Executive Officer Dara Khosrowshahi said he will not attend an investment conference in Bahrain's ally, Saudi Arabia. Khosrowshahi is among several business leaders who have said they are pulling out of the three-day investment conference slated to take place in Saudi Arabia beginning October 23. Porsche, the sports car maker owned by Volkswagen AG, has denied speculation that it plans to pursue an initial public offering or IPO. Porsche Chief Financial Officer Lutz Meschke said on Friday that Porsche was discussing a potential listing of a group combining Porsche, Bentley, Lamborghini and Bugatti, with a potential value of up to 70 billion euros. Bank of America (BAC) reported that its third-quarter earnings per share was up 43% year-over-year to $0.66. On average, 24 analysts polled by Thomson Reuters expected the company to report profit per share of $0.62 for the quarter. Analysts' estimates typically exclude special items. Net income to shareholders...
Follow RTT