Published: Wed, July 18, 2018
Medical | By

Local Valsartan not recalled

Local Valsartan not recalled

Several US companies had already begun voluntarily recalling products containing Huahai's valsartan after the FDA statement.

Certain lots of the therapy, distributed under the Actavis label in the USA, have been detected to have trace amounts of probably human carcinogen N- nitrosodimethylamine (NDMA).

Revealing that the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured, the official asked doctors to take necessary measures to protect the users of those drugs from NDMA complications and report side-effects or adverse events to the DRAP. If the information is not there, patients should contact the pharmacy where they got it, the FDA said. Not all medicines containing the ingredient have been recalled.

Users prescribed drugs with the presence of valsartan are encouraged to continue taking the recalled drug until they're able to speak with their doctor for alternative options.

Zhejiang Huahai Pharmaceutical produces the active substance Valsartan. The list of recalled products has been posted on the websites of many regulatory agencies, including the U.S. FDA, Health Canada, the Irish Regulatory Authority and the Jamaica Ministry of Health.

The recall in the United States includes versions of valsartan made by Solco Healthcare, Major Pharmaceuticals and Teva Pharmaceuticals Industries.

"We need to think globally and work strategically with partners from around the world to make best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured". Zhejiang Huahai Pharmaceuticals supplied the three US -based pharmaceutical companies with these products, according to The New York Times.

"When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we're committed to taking swift action to alert the public and help facilitate the removal of the products from the market", said Commissioner Dr. Scott Gottlieb.

According to the EMA, it is investigating the levels of NDMA in these valsartan medications, its possible impact on users, and steps to reduce or eliminate the impurity from future batches produced by the Chinese company.

"It's not just valsartan", Lever said.

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