The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party. Pharmacies in the United Kingdom are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare.
The agency is telling that traces of N-nitrosodimethylamine (NDMA) "probable human carcinogen", was found in the active ingredient valsartan in the recalled products.
The agency also said that patients taking valsartan, or medicines that use it as an ingredient, should continue taking it until they have a substitute.
Several US companies had already begun voluntarily recalling products containing Huahai's valsartan after the FDA statement.
Valsartan was originally developed by Novartis and the Swiss company marketed it as Diovan, but it is now off patent and is used in a number of generic medicines supplied by various companies.
When contacted, DRAP deputy director (quality control) Abdul Sattar Sohrani confirmed the recall orders and said the pharmaceutical firms concerned had been given one week to remove from the market the medicines made from Zhejiang Huahai's valsartan. "That is why we've asked these companies to take immediate action to protect patients". The FDA noted not all products containing valsartan are contaminated and being recalled.
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To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle.
Blood pressure meds have been recalled over cancer fears after it was discovered that the widely prescribed drug may contain a carcinogen, Time magazine reported. Zhejiang Huahai Pharmaceuticals supplied the three US -based pharmaceutical companies with these products, according to The New York Times. The presence of NDMA is thought to be related to changes in the way the active substance was manufactured. It is commonly used in combination with hydrochlorothiazide to treat hypertension.
Also, you should contact your doctor of whoever the pharmacists was that dispensed the impacted drugs to you to discuss an alternative option. "Not all the products are recalled, just certain manufacturers".
This is the list of medications recalled by the FDA.
This incident raises serious questions regarding the quality methods employed by the Pakistan Pharmaceutical Manufacturing Industry (PPMI).