Zhejiang Huahai Pharmaceutical - a major supplier of the active ingredient valsartan that it uses to make a generic blood pressure drug - raised the alarm and voluntarily suspended its supplies in the worldwide market after detecting an impurity, N-nitrosodimethylamine (NDMA) in the product.
You should also follow the recall instructions provided by the specific company.
Huahai has said it is unable to determine how much it will lose from the recall, but its own data shows that sales of valsartan, which is mostly sold to North America, Europe, India, Russia and South America, totaled CNY328 million (USD49 million) past year, compared with total revenue of CNY5 billion (USD749 million). Only the ones that have N-nitrosodimethylamine (NDMA) are being recalled.
European Union authorities have been recalling medicines containing valsartan from Zhejiang Huahai over the past two weeks and the EMA said such medicines should no longer be available in pharmacies.
"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. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. "As a precaution, the review will also consider whether other valsartan medicines may be affected". The agency is still investigating, but said the contamination was believed to be related to changes in the way that valsartan was manufactured.
Prinston Pharmaceutical, doing business as Solco Healthcare, is recalling "all lots" of Valsartan tablets manufactured by Zhejiang Huahai Pharmaceutical. "There is no certainty as to how much this contaminant may potentially increase cancer risk in humans".
The FDA's investigation into the drug will continue. "The FDA is committed to maintaining our gold standard for safety and efficacy", said FDA Commissioner Scott Gottlieb, M.D.
The Ministry of Health and Wellness will continue to follow warnings from the worldwide regulatory agencies with respect to any changes in pharmaceutical products to continue to ensure the availability of safe and quality products to the public. "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".
Patients and doctors are being warned to ensure that the valsartan that they are taking is not being manufactured by this particular company. Going off their medication without supervision could be unsafe, according to the American Heart Association.