An impurity called N-nitrosodimethylamine (NDMA) was found in several of products containing valsartan, which is used to treat heart failure and high blood pressure. Patients who are on valsartan should continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
Interesting thing is that every single of the carcinogenic medicines are made in China and also by the same company named as Zhejiang Huahai Pharmaceuticals Co. Ltd.
However, the DRAP orders won't affect the medicines containing valsartan produced by other companies.
Addressing a possible shortage due the recall, FDA Commissioner Scott Gottlieb, MD, said "As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients' therapeutic needs are met in the United States with an adequate supply of unaffected medications".
FDA has asked the patients not to take any medicine manufactured by this company and do not buy any product in which there is no name of the manufacturer.
Companies impacted by the recall have shared instructions for patients impacted by these products. To determine if you're medication has been recalled, look at the drug name and company name on the label of your prescription bottle. The valsartan contained in the recall was supplied by a third-party.
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The FDA has said it will "continue to investigate this issue and provide additional information when it becomes available". The FDA said the reason the NDMA was in the medications is "thought to be related to changes in the way the active substances was manufactured".
Zhejiang Huahai, which was founded in 1989 and listed on the Shanghai stock exchange in 2003, was one of the first Chinese companies to get drugs approved in the USA market.
The recall, which also includes valsartan-hydrochlorothiazide tablets, followed a similar action taken by the European Medicines Agency.
Major Pharmaceuticals said that the recalled products were distributed to "wholesale and retail facilities, including hospitals and pharmacies" nationwide.
Prinston Pharmaceutical, doing business as Solco Healthcare, is recalling "all lots" of Valsartan tablets manufactured by Zhejiang Huahai Pharmaceutical.
Don't stop using the medication if you are affected by the recall.