The FDA has named the companies which will engage in a voluntary recall of their products - it includes Teva Pharmaceuticals, Major Pharmaceuticals and Solco Healthcare for their valsartan medicine, and Teva and Solco for their valsartan/hydrochlorothiazide (HCTZ) medicine.
As a result, the Drug Regulatory Authority of Pakistan (Drap) triggered a recall of all valsartan containing medicines having made using same source of active substance.
A request for a class-action suit filed in the Montreal courthouse on Monday wants the manufacturers of a recalled heart medication, valsartan, to pay damages to Quebecers who took the drug.
A similar recall notification issued by the Provincial Pharmacovigilance Centre of Punjab on July 16, 2018, named a number of local pharmaceutical companies who are allegedly importing the contaminated raw material from China. Last year, Huahai sales topped US$ 49 million, mainly in North America, Europe, India, Russia and South America. He said the DRAP would strictly enforce its recall orders.
"The FDA is committed to maintaining our gold standard for safety and efficacy". Their health care provider should be able to offer other treatment options, among them, another valsartan product that is not part of the recall.
The recall is due to the presence of the impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, according to an FDA statement. In the meantime, the Agency plans to continue its investigation into the possible effects NDMA might have on patients who have been taking these products.
Patients are advised to look at the company and the drug name mentioned on the label of their prescription to see whether the specific product is recalled or not.
You can find more information about the recall here. Major Pharmaceuticals as a distribution firm, is recalling all lots within expiry of Valsartan supplied by Teva Pharmaceuticals.
This incident raises serious questions regarding the quality methods employed by the Pakistan Pharmaceutical Manufacturing Industry (PPMI).
Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient supplied by this specific company. NDMA is classified as carcinogenic. In humans, exposure to high levels of NDMA can damage the liver and is probably a human carcinogen. It has been used to make liquid rocket fuel, softeners and lubricants, among other products. It is now used only for research purposes.
This information will be posted on the FDA's website.
As valsartan is used to treat various cardiovascular conditions including heart failure and hypertension, patients should continue to take their medications until they have a replacement product.