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Several drug companies have recalled drugs containing valsartan, a non-patented ingredient used in generic drugs to treat heart failure and high blood pressure.
The companies have accused the recall of the presence of N-nitrosodimethylamine (NDMA), the impurity that it is thought produced due to changes in manufacturing that is classified as a probable carcinogen.
The Food and Drug Administration published an announcement on voluntary recalls on July 13th. Twenty-two other countries also published varlsartan recalls
The specific products impacted are valsartan sold by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries, and valsartan / hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals.
"We have carefully evaluated valsartan containing drugs sold in the United States, and we have found that the valsartan sold by these specific companies does not meet our standards," said Janet Woodcock, director of the Center for Drug Therapy. FDA drug evaluation and research, in a statement. "That's why we asked these companies to take immediate action to protect patients."
FDA urges patients to continue to take the drugs until they can be replaced because they are used to treat "serious conditions." The agency also recommends that consumers determine whether they take a product recalled, find company specific recall instructions and contact their pharmacy and their doctor.
FDA spokesperson declared Fortune dates of the medico Affected items will be provided by the drug companies and posted on the FDA website. Solco Healthcare's information is already on the FDA website, and information from Major Pharmaceuticals can be found on its website. Fortune contacted Teva Pharmaceutical for further information and will update it if necessary
Prinston Pharmaceutical, doing business under the name of Solco Healthcare, recalls "all lots" of Valsartan tablets manufactured by Zhejiang Huahai Pharmaceutical. The listed drugs include "40 mg, 80 mg, 160 mg and 320 mg; and Valsartan-HCTZ Tablets, 80mg / 12.5mg, 160mg / 12.5mg, 160mg / 25mg, 320mg / 12.5mg, and 320mg / 25mg, in the due dates from July 2018 to Jan 2020, "according to a The company is asking pharmacies to "immediately return the product."
Major Pharmaceuticals stated that the recalled products were distributed to "wholesale and retail establishments, including hospitals and pharmacies" at The medications concerned were provided by Teva Pharmaceuticals and include Valsartan 80 mg tablets and Valsartan 160 mg tablets with the expiration dates of July 2018, February 2019 or May 2019. (A full list of lot numbers can be found here.)
To date, neither Prinston Pharmaceutical nor Major Pharmaceuticals have received any adverse effects reports from the recalled products. Consumers may report problems. my to the FDA through the agency's MedWatch Adverse Event Reporting program, which can be contacted by phone, fax, mail or online.
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